MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	71331946
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that oxinium femoral head was revised due to patient was non compliant with post operative precautions, then had recurrent dislocations of hip.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that it was reported that the patient was non-compliant with post op precautions and had recurrent dislocations of hip.A revision right thr was performed three months post op.No clinical relevant supporting documents were provided to conduct a thorough medical assessment of the reported hip dislocation.Without the surgical findings, medical documents, x-rays, or explants for analysis the root cause of the reported dislocations cannot be definitively concluded.However, the patient¿s reported non-compliance with post-op precautions is likely a contributory factor.The future impact to the patient cannot be determined.Based on the information provided no further clinical assessment is warranted at this time.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Event or Problem Description
It was reported that revision surgery was performed due to recurrent dislocations of hip since the patient was non compliant with post operative precautions.Surgeon decided to revise with competitor cup.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 46MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7974354
• Report Number: 1020279-2018-02202
• Device Sequence Number: 11243174
• Product Code: JDH
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: No Information
• Device Model Number: 71331946
• Device Catalogue Number: 71342804
• Device Lot Number: 17KM03497
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT: 71332515LOT: 17HB00211; CAT: 71332520LOT: 14GMB0014A; CAT: 71332525LOT: 18AB00569; CAT: 71334946LOT: 09FM18019; CAT:71342804LOT: 17LM16310
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention