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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the head of the prothesis came out of the polyethylene and led to a dislocation of the prothesis.A revision surgery had to be performed with a new head and insert being fitted.
Additional Manufacturer Narrative
Results of investigation: a dislocation of the ball head from a polarcup xlpe insert.A revision surgery had to be performed with a new head and insert being fitted.The insert and the ball head were returned.No signs of excessive wear were observed on any of the components.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No indications of dimensional deviation at the time of manufacturing were detected on the devices.No medical records have been provided for review.The length of time the implant was in situ prior to the dislocation is unknown.However several x-ray images have been provided and reviewed, an image confirming the dislocation is dated two weeks later than the post-implantation image.It has been further communicated that patient is a chronic alcoholic, and the influence of alcohol on the patient has caused several falls which ultimately resulted in the dislocation of the prosthesis in the surgeon's opinion.Based on the performed investigation the root cause of the reported issue is considered to be unrelated to the product.No further investigation have been initiated.

• 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: 7166326
• Report Number: 1020279-2018-00025
• Device Sequence Number: 13941009
• Product Code: LPH
• UDI-Device Identifier: 03596010194145
• UDI-Public: 03596010194145
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2018

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
• Device Lot Number: 17JT92628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 12/19/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/28/2018; 08/10/2018
• 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