MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: RECONSTRUCTION; PLATE,FIXATION,BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 154.90 cms.This report is for an unknown reconstruction plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 3 of 5 for (b)(4).This report is for an unknown reconstruction plate.

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.There is no known remedial action initiated for this unknown device.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: 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 history lot 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.The implant(s) was not returned and instead will be do based on the supplied image(s) from the attachments (2337 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) was reviewed and the complaint condition for adverse event could not be confirmed as the image(s) showed no issues with the product.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the supplied image(s).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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: UNK - PLATES: RECONSTRUCTION
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8683560
• MDR Text Key: 147482658
• Report Number: 2939274-2019-58576
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• 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