MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71342804
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation to remove head and competitor's liner.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.These devices were manufactured in 2018.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should patient specific clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Of note, it was communicated that the head had been implanted with a competitor liner and required revision after dislocation.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include traumatic injury or improper sizing.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.

• Brand Name: OXINIUM FEM HD 12/14 28MM +4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8929184
• Report Number: 1020279-2019-03186
• Device Sequence Number: 242289
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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 Model Number: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 18LM05923
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 04/14/2020
• 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: 69 YR