MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery had been performed on (b)(6) 2020, a revision surgery for the r3 3 hole acet shell 52mm had to be performed on (b)(6) 2021.The clinical outcome of the patient was reported as "recovered".
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
D4: part number and lot number updated.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per the case report forms, the patient reported pain and clicking her hip.It also indicated a magnetic resonance imaging showed fluid collection within the subcutaneous tissues about the lateral aspect of the right hip.According to the case report forms the hip was revised due to dislocation.Based on the limited information provided, there were no clinical factors found which would have contributed to the reported dislocation and subsequent revision.The patient impact beyond the revision surgery could not be determined.However, the adverse event has been reported as recovered/resolved.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral head, insert, liner and shell, a review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the stem, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the femoral head, insert, liner and shell, a review of the instructions for use documents for total hip systems revealed in warnings and precautions that dislocation may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.For the stem, a review of the instructions for use documents states joint dislocation of the component as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.For the femoral head, insert, liner and shell, a review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the stem, a review of the risk management file revealed this failure mode is not applicable to the underlaying device.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 3 HOLE ACET SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16883068
• Report Number: 1020279-2023-00993
• Device Sequence Number: 5822663
• Product Code: MBL
• UDI-Device Identifier: 03596010488879
• UDI-Public: 03596010488879
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 71335552
• Device Catalogue Number: 71342204
• Device Lot Number: 20BM19418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 06/06/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OR3O DM XLPE INSERT 22/40, LOT#:A1922678; OR3O DUAL MOBILITY LINER 40/52, LOT#:20EM02424; POLARSTEM STEM LAT.TI/HA 1 NON-CEM, LOT#:B1902557; R3 3 HOLE ACET SHELL 52MM, LOT#:20FW00924
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG