MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 ANT +4 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333435
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed.On inspection the constrained poly was broken as well as the locking ring.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that the provided image and the reported intra-operative findings support the complaint of the fractured locking ring and possible dislocation.However, without further clinical relevant patient history and analysis of the explanted components the root cause of the reported event remains unknown.The patient impact beyond the revision surgery with the minor surgical delay and an expected brief convalescence period cannot be determined.No further medical assessment can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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 32 20 ANT +4 54-56 F
• 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: 7931220
• Report Number: 1020279-2018-02035
• Device Sequence Number: 1914021
• Product Code: LPH
• UDI-Device Identifier: 03596010480460
• UDI-Public: 03596010480460
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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 Expiration Date: 09/30/2014
• Device Catalogue Number: 71333435
• Device Lot Number: 04JM14239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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