MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 28 -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302803
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to pain in thigh external and internal rotation.
Additional Manufacturer Narrative
The associated cobalt chrome femoral head, the insert and the shell were not returned for evaluation.Therefore, no product analysis could be performed.However, device details were provided.After repeated requests, smith and nephew has been unable to obtain device details for the insert and the shell.Product information has been provided only for the head.Thus, our investigation including the manufacturing records and complaint history review was conducted on the related part.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that x-rays provided could support stem subsidence but this cannot be confirmed.Based on the limited information provided the root cause of the reported to thigh pain and external and internal rotation cannot be determined.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.The impact to the patient beyond the revision cannot be concluded.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HD 28 -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8628221
• Report Number: 1020279-2019-01998
• Device Sequence Number: 2293214
• Product Code: LPH
• UDI-Device Identifier: 03596010194121
• UDI-Public: 03596010194121
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Catalogue Number: 71302803
• Device Lot Number: 17LM05168
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR