MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 71306613

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

Patient Problem Nerve Damage (1979)

Event Date 01/28/2020

Event Type  Injury  

Event Description

*us legal* it was reported that a medically indicated intervention was performed on (b)(6)2020 due to to nerve palsy of the sciatic nerve.On the procedure it was found that there was a significant amount of scar and adhesions around the nerve at the sciatic nerve area.The repair was taken down and the adhesions carefully freed from the nerve.The patient outcome is unknown.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported elevated metal ions and intraoperative findings of metallosis may be consistent with findings associated with metal debris.Without supporting radiographic images, and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.Additionally, the clinical root cause of the reported peroneal nerve palsy cannot be concluded.The known patient impact is limited to the revision, the peroneal nerve palsy, the wound exploration and sciatic nerve lysis.No further clinical assessment is warranted at this time a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SYN POR FEM COMP SZ 13
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11593555
• MDR Text Key: 243094153
• Report Number: 1020279-2021-02571
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010194473
• UDI-Public: 03596010194473
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: 71306613
• Device Catalogue Number: 71306613
• Device Lot Number: 09EM14685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention