MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 0 DEG 46-48 SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that revision surgery was performed due to wear.Unknown how the procedure finished, if occurred a surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per complaint details, approximately 8 years post implantation, the patient underwent revision due to ¿wear¿.Reportedly, the component ¿wear¿ was the root cause of the revision; however, responses to the requested clinical documentation were not provided.Based on the information provided, the root cause could not be definitively concluded, although wear is a known potential occurrence.The patient impact beyond the reported component wear and subsequent revision could not be determined.In the event additional medical/clinical records are received, the clinical task may be re-opened and a re-assessment may be performed at that time.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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 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.Potential causes could include but are not limited to friction, joint tightness or abnormal motion over time.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: REF XLPE 28 0 DEG 46-48 SZ D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11056376
• Report Number: 1020279-2020-07696
• Device Sequence Number: 17034589
• Product Code: JDI
• UDI-Device Identifier: 03596010455857
• UDI-Public: 03596010455857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: 71333373
• Device Catalogue Number: 71333373
• Device Lot Number: 12FM03867
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1