MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS

Model Number	71334946
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a closed reduction due to dislocation.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms it cannot be determined to what extent the patient¿s history of spinal fusion, increased combined anteversion and soft tissue laxity had on her dislocation.The root cause of the dislocation post second revision cannot be determined and it cannot be concluded that the dislocation is associated with a mal-performance of the implant.The patient impact beyond the dislocation and reduction cannot be determined.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 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.Some potential probable causes for this event could include improper surgical technique, device selection or patient anatomy.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 28MM X 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9520282
• Report Number: 1020279-2019-04600
• Device Sequence Number: 13602029
• Product Code: MBL
• UDI-Device Identifier: 03596010598097
• UDI-Public: 03596010598097
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2021

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?: No
• Operator of Device: No Information
• Device Expiration Date: 10/17/2025
• Device Model Number: 71334946
• Device Catalogue Number: 71334946
• Device Lot Number: 15KM13975
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 04/09/2020; 08/13/2021
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/14/2020; 08/16/2021
• 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: Required Intervention