MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 28 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302804
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of r3 hole cup size 46 with 20 degree 28/46 liner and cocr femoral head sz 28 due to osteolysis causing wear on the liner.Original total hip was completed in the 1990's unable to locate exact dates.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell, r3 20 deg xlpe acetabular liner and cobalt chrome femoral head were not returned for evaluation.A clinical evaluation noted that based on the limited medical information provided and without the return of the explant the root cause of the wearing of the liner could not be concluded but length of time the devices were implanted cannot be ruled out as a factor.The one undated x-ray confirms reported findings and the wearing of the liner.The impact to the patient beyond the revision cannot be concluded.Following the revision it was reported the patient is not experiencing any further issues.After repeated requests, smith and nephew has been unable to obtain device details for the liner and the shell of this complaint.Therefore, a review of device history record and complaint history cannot be completed.Smith and nephew has an outstanding request with the reporter for information.Batch number for the femoral head was provided.A review of the complaint history for the device revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product 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 the device or additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HD 28 + 4
• 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: 8123192
• Report Number: 1020279-2018-02637
• Device Sequence Number: 19204239
• Product Code: LPH
• UDI-Device Identifier: 03596010194138
• UDI-Public: 03596010194138
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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 Expiration Date: 11/22/2008
• Device Catalogue Number: 71302804
• Device Lot Number: 81008243
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 04/17/2019
• 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