MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF ALL POLY 32ID 49OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71358034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Only the femoral head and poly cup were changed in the revision.The cpcs stem stayed in.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical task concluded, without sufficient documentation and/or the analysis of the explanted components the root cause of the dislocation cannot be determined, although it is likely that migration of the cup into a suboptimal position contributed.The reported dislocation was the contributing factor the right tha revision.The patient impact beyond the dislocation, probable pain, and right hip revision procedure cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products 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 batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: REF ALL POLY 32ID 49OD XLPE
• 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: 7630121
• Report Number: 1020279-2018-01172
• Device Sequence Number: 2412838
• Product Code: LPH
• UDI-Device Identifier: 03596010474247
• UDI-Public: 03596010474247
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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: 05/24/2026
• Device Catalogue Number: 71358034
• Device Lot Number: 16ET70036
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 11/04/2018
• 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