MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.009S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Implant date is on or about (b)(6) 2015.Exact date is unknown.Explant date is on or about (b)(6) 2015.Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review has been requested.Product was not returned.Based on the information available, it has been determined that no corrective and 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 or about (b)(6) 2015, patient underwent surgery for his right elbow radial head replacement.During the surgery, patient was implanted with radial head implant.Following the replacement surgery, patient began to experience increasing pain and decreased function of his elbow and was presented to orthopedic surgeon, who confirmed the loosening of the radial head prosthesis.On the surgeon's recommendation, on or about (b)(6) 2015, patient underwent removal of the radial head prosthesis without replacement of the radial head.The surgeon recommended not to replace the radial head component unless patient subsequently experience instability and pain of the elbow.Within a few months of the implant being removed, patient developed worsening pain and instability of his right arm which necessitated replacement of the radial head prosthesis.On or about (b)(6) 2016, patient underwent surgery to replace the right elbow radial head.Patient was revised with radial head implant system.After the revision surgery, patient began to develop pain in his elbow and presented back to his orthopedic doctor, who confirmed loosening of the revised radial head implant and recommended re-revision surgery.Patient is in the process of scheduling re-revision surgery.This (b)(4) captures removal due to pain on (b)(6) 2015.(b)(4) captures the re-revision surgery required due to pain following revision of on or about (b)(6) 2016.This report is for one (1) radial stem.This is report 2 of 2 for (b)(4).

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.Initial reporter is a lawyer.Manufacturing location: supplier - (b)(4) , packaged and released by: monument; manufacturing date: december 10, 2014; expiration date: october 31, 2019; part: 04.402.009s, 9mm ti straight radial stem 30mm ¿ sterile; lot: 7785142 (sterile); lot quantity: 100 work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign 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.Sterilization control number (scn) 10819 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility 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: 21014, tialnbri16.00; lot: 7557656; lot quantity: 3,059 lbs.Certified test report supplied by perryman company and inspection certificate supplied by vsmpo were reviewed and determined to be conforming.Lot summary report 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.

Event Description

It was reported that on (b)(6) 2015, the patient underwent removal surgery of the radial head prosthesis due to loosening.Originally, the radial head implant system was implanted on (b)(6) 2015.Following the implantation, the patient began to experience increasing pain, decreased function and weakness of his elbow and loss of range of motion.The implants were removed without replacement of the radial head.During the removal, it is unknown if there was a surgical delay.After the implant removal, the patient continued to experience worsening pain and instability in his right arm.On (b)(6) 2017, upon clinic visit, the patient reported that the right elbow still had occasional severe sharp pain with mechanical symptoms from loose radial head arthroplasty.

• Brand Name: 9MM TI STRAIGHT RADIAL STEM 30MM-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: 8274881
• MDR Text Key: 134011487
• Report Number: 2939274-2019-56043
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128065
• UDI-Public: (01)10886982128065
• 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
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 04.402.009S
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7785142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR