MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336448
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation and pain.
Additional Manufacturer Narrative
The affected reflection xlpe liner, cobalt chrome femoral head and reflection three hole shell were not returned for evaluation.A clinical evaluation noted no clinically relevant patient information was provided for this complaint.Therefore, a thorough medical investigation/assessment cannot be performed.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 batch.Without the actual product involved, our investigation of this report is inconclusive.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 THREE HOLE SHELL 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7358969
• Report Number: 1020279-2018-00364
• Device Sequence Number: 2023509
• Product Code: MBL
• UDI-Device Identifier: 03596010454331
• UDI-Public: 03596010454331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/25/2018

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: 09/24/2020
• Device Catalogue Number: 71336448
• Device Lot Number: 10JM17552
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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; Required Intervention
• Patient Age: 80 YR