MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338664
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	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery that had been performed on (b)(6) 2023, the patient experienced a dislocation.An anteversion of the r3 cup was noted to be a little insufficient.A revision surgery was perfomred on (b)(6) 2023, in which the cup, liner and screw were exchanged to competitor products (zimmer).Also, the femoral head was exchanged to oxinium head, just the stem was not explanted.However, the surgeon did not think it was a failure of the devices reported.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, after thr surgery that had been performed on (b)(6) 2023, the patient experienced a dislocation.A revision surgery was performed on (b)(6) 2023, in which the anteversion of the r3 cup was noted to be a little insufficient, the cup, liner and screw were exchanged for competitor products (zimmer).Also, the femoral head was exchanged to oxinium head, just the stem was not explanted.The surgeon did not think it was a failure of the devices.No further information is available.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, no clinical/medical records were provided; therefore the assessment and conclusion are based on the reported events.The anteversion of the r3 cup being ¿a little insufficient¿ is a possible contributing factor to the reported dislocation and subsequent revision.The surgeon did not think it was a failure of the devices which indicates it may be placement of the shell.The patient impact is the associated symptoms of the dislocation and associated treatments along with the reported revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the cup and liner part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of complaint history revealed similar events for the listed head over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product 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, implant size, 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 MULTI HOLE ACETABULAR SHELL 50MM
• 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: 18120750
• Report Number: 1020279-2023-02221
• Device Sequence Number: 20551642
• Product Code: MBL
• UDI-Device Identifier: 00885556020630
• UDI-Public: 00885556020630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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 Catalogue Number: 71338664
• Device Lot Number: 23EM05475
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female