MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR FEM 12/14 FEM HD 28 + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302808
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to peri-prothetic fracture.Head and liner were replaced.Devices won't be returned.
Additional Manufacturer Narrative
The associated reflection liner and cobalt chrome femoral head were not returned for evaluation.Therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch number.Our investigation including a clinical evaluation noted that the root cause of the peri-prosthetic fracture could not be determined based solely on the one x-ray image provided; however, the approximate 20.5 years in vivo, probable wear particles and impingement with the liner, and declining bone quality were likely contributing factors to the reported event as profound rim poly wear was demonstrated on the explant photos.The patient impact beyond the revision procedure and an expected brief post-operative rehab phase could not be concluded.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.Without the return of the actual product involved and batch information available, 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.

• Brand Name: COCR FEM 12/14 FEM HD 28 + 8
• 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: 8660900
• Report Number: 1020279-2019-02128
• Device Sequence Number: 2446028
• Product Code: LPH
• UDI-Device Identifier: 03596010194145
• UDI-Public: 03596010194145
• 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 Implanted Year: 1999
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: 71302808
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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