MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71339548
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unknown reasons.Liner explanted.Further information requested.
Event or Problem Description
It was reported that the patient was participating on the "multi-center, randomized controlled study of efficacy and safety of the oxinium dh total hip replacement system in subjects with non-inflammatory arthritis study" and underwent a revision surgery of the head, shell and liner due to unknown reasons.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Reportedly, the root cause of the revision was unknown.It was communicated that the ¿patient was part of the control group for the ox on ox tha study and had complications¿; however, further detailed were unknown.The patient impact beyond the reported revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to abnormal motion over time, bone degeneration fit/sizing, lack of ingrowth, traumatic injury.And surgical complication.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or some potential probable causes that could contribute to the reported event include but not limited to overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 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: 9187374
• Report Number: 1020279-2019-03643
• Device Sequence Number: 1724539
• Product Code: MBL
• UDI-Device Identifier: 03596010598790
• UDI-Public: 03596010598790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2020

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: 71339548
• Device Catalogue Number: 71339548
• Device Lot Number: 17JM04606
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 08/07/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/25/2020; 08/11/2020
• 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