MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338666
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Joint Dislocation (2374)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha had been performed, the patient experienced two dislocations that requiered relocation of the joint.For the third dislocation therefore patient had to be taken to the or.A revision surgery was performed to treat this event.The synergy stem was well fixed, but the surgeon felt like the r3 multi hole acetabular shell 54mm was malpositioned; therefore, it was removed.The r3 20 deg xlpe acet lnr 36mm x 58mm and cocr 12/14 fem head 36mm +0 were also removed.The surgeon repositioned the cup and implanted a redapt modular cup with or30 assembly, acetabular screws and 28mm oxinium head.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, approximately 1.5 years post tha, the patient underwent a revision due to recurrent dislocations post relocations (reductions) x 2.Reportedly, the stem was well fixed; however, ¿the surgeon felt like the cup was malposition¿.It was communicated that the requested op notes and x-rays were not available for inclusion in the medical investigation.Based on the information provided, the reported malpositioned cup could not be ruled out as a potential contributing factor to the reported events, although the definitive root cause could not be concluded.The patient impact beyond the reported dislocations, reduction, and head/liner/shell revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, fit/ sizing issue or poor insertion technique.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.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11250218
• Report Number: 1020279-2021-00761
• Device Sequence Number: 3583272
• Product Code: MBL
• UDI-Device Identifier: 00885556021804
• UDI-Public: 00885556021804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71338666
• Device Catalogue Number: 71338666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: COCR 12/14 FEM HEAD 36MM +0; R3 20 DEG XLPE ACET LNR 36MM X 58MM; COCR 12/14 FEM HEAD 36MM +0; R3 20 DEG XLPE ACET LNR 36MM X 58MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention