MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problems Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Discomfort (2330); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 154.90 cms.This report is for an unknown radial stem prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code for no code available is for surgical intervention, medical device removal and loss of anatomical alignment.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, the patient underwent removal of hardware upper extremity allograft (right elbow) because of radial head implant loosening as well as osteolysis around the other metal in her elbow.On (b)(6) 2015, the patient suffered a fall and sustained a transolecranon fracture dislocation of the right upper extremity.She underwent open reduction and internal fixation (orif) of the olecranon with radial head arthroplasty using a synthes radial head.A 3.5 mm variable angle proximal ulnar locking plate was placed over the dorsal and cortical screws were placed distally to bring the plate flush with the bone.In order to assist with capturing the comminuted metaphyseal fragments, a medially-based 2.0 mm reconstruction plate with 2.4 mm screws completed the construct with orthogonal fixation of the comminution of the metaphysis.In order to secure the repair of the lateral side, a g-2 mitek suture were then used to repair the lcl.On (b)(6) 2018, during follow-up visit, patient was currently booked for hardware removal, patient presents with pain.The radiographic examination/diagnostics presents; quite significant osteophyte lysis and migration of the radial head.Assessment results present; closed monteggia¿s fracture of right ulna with routine healing ostial lysis secondary to radial head.On (b)(6) 2018, during follow-up visit, the patient presented with right arm clicking and discomfort with pain scale of 6 (0-10 numeric rating scale).The pain interferes with the patient¿s sleep and limits the desired activities.On (b)(6) 2018, the patient underwent removal of implants; synthes radial head prosthesis, and synthes plates and screws.Findings of progressive loosening of the implant as well as osteolysis around the other metal in her elbow.Incision over the ulna was made with dissection carried down through skin level of the bone.Here, the plate was identified and all screws were removed without difficulty.A separate incision through the kocher interval was made, dissection carried down through skin level of the kocher interval which was opened revealing the radial head.The radial head was identified with some small amount of heterotopic bone around its rim.This was excised to give access to the radial head which was then excised without difficulty.Following this, wounds were irrigated.The elbow was ranged without crepitus.A suture anchor as well as a medially placed screw were left in position as dissection to remove them would cause more harm than good.The patient¿s family was informed of this decision.Closure than proceeded in layers with vicryl and monocryl sutures.Following the removal hardware surgery, the patient was happy with her progress since surgery noting an improvement in pain and function.Concomitant devices reported: mitek g-4 suture ancho.This is report 2 of 5 for (b)(4).This report is for an unknown radial stem prosthesis.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Updated event description: it was reported that on (b)(6) 2018, the patient underwent removal of hardware upper extremity allograft (right elbow) because of radial head implant loosening as well as osteolysis around the other metal in her elbow.On (b)(6) 2015, the patient suffered a fall and sustained a transolecranon fracture dislocation of the right upper extremity.She underwent open reduction and internal fixation (orif) of the olecranon with radial head arthroplasty using a synthes radial head.A 3.5 mm variable angle proximal ulnar locking plate was placed over the dorsal and cortical screws were placed distally to bring the plate flush with the bone.In order to assist with capturing the comminuted metaphyseal fragments, a medially-based 2.0 mm reconstruction plate with 2.4 mm screws completed the construct with orthogonal fixation of the comminution of the metaphysis.In order to secure the repair of the lateral side, a g-2 mitek suture were then used to repair the lcl.On (b)(6) 2018, during follow-up visit, patient was currently booked for hardware removal, patient presents with pain.The radiographic examination/diagnostics presents; quite significant osteophyte lysis and migration of the radial head.Assessment results present; closed monteggia¿s fracture of right ulna with routine healing ostial lysis secondary to radial head.On (b)(6) 2018, during follow-up visit, the patient presented with right arm clicking and discomfort with pain scale of 6 (0-10 numeric rating scale).The pain interferes with the patient¿s sleep and limits the desired activities.On (b)(6) 2018, the patient underwent removal of implants; synthes radial head prosthesis, and synthes plates and screws.Findings of progressive loosening of the implant as well as osteolysis around the other metal in her elbow.Incision over the ulna was made with dissection carried down through skin level of the bone.Here, the plate was identified and all screws were removed without difficulty.A separate incision through the kocher interval was made, dissection carried down through skin level of the kocher interval which was opened revealing the radial head.The radial head was identified with some small amount of heterotopic bone around its rim.This was excised to give access to the radial head which was then excised without difficulty.Following this, wounds were irrigated.The elbow was ranged without crepitus.A suture anchor as well as a medially placed screw were left in position as dissection to remove them would cause more harm than good.The patient¿s family was informed of this decision.Closure than proceeded in layers with vicryl and monocryl sutures, following the removal hardware surgery, the patient was happy with her progress since surgery noting an improvement in pain and function.Concomitant devices reported: mitek g-4 suture anchor this complaint involves five (5) devices.Customer quality investigation: device condition: visual inspection performed at customer quality on the device images provided showed no issues of stem loosening.Per all the images (2337 images from the attachments located in notes & attachments section of the product complaint) reviewed, the complaint was not able to be confirmed by us cq.However, there are known issues with the radial head implants.There is also a recall (recall# 555531) that was initiated as part of field action investigation.Document/specification review: a manufacturing record review, could not be performed as the lot number could not be determined.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and hhe-2016-180 investigations.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the corrected lot number; expiration date.Corrected device manufacture date.Corrected device history record (dhr) review: manufacturing location: supplier (b)(4), packaged by: monument, manufacturing date: 28-jul-2014, expiration date: 30-jun-2019.Part #: 04.402.008s, lot#: 7607062 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 143.Components: part 21014 lot: 6190711.Raw material lot number 7557656 reviewed.Raw material provided by avalign company.Avalign product certification for titanium meets specification.Inspection sheet for incoming final inspection meets specification.Non conformance report (ncr) initiated on 07-jul-2014 for ¿number projected was not completed on final inspection¿ which is not relevant to complaint condition of hardware loosening.Scn: sterility documentation was reviewed and determined to be conforming.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument release to warehouse date: 01-jul-2014 expiration date: 30-may-2019 part number: 09.402.022s, 22mm cocr radial head standard height/ 12.5mm ¿ sterile lot number: 7607082 (sterile) lot quantity: 150 work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 16-may-2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 10376 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21022, tialnbri8.00 lot number: 5317556 lot quantity: 956 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Product certification supplied by dynamet dated 27-sep-2006 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40 lot number: 7264642 lot quantity: 305 lbs.Certificate of tests supplied by carpenter dated 31-jan-2013 was reviewed and determined to be conforming.Lot summary report dated 14-feb-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device condition: visual inspection performed at customer quality on the device images provided showed no issues of stem loosening.Per all the images (2337 images from the attachments located in notes & attachments section of the product complaint) reviewed, the complaint was not able to be confirmed by us cq.However, there are known issues with the radial head implants.Relevant actions have been taken to address the issue.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled.Any related investigations and assessment of the risks associated with this system will be covered.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8683414
• MDR Text Key: 147479070
• Report Number: 2939274-2019-58573
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7607062
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: MITEK G-4 SUTURE ANCHOR; MITEK G-4 SUTURE ANCHOR
• Patient Outcome(s): Required Intervention
• Patient Weight: 81