MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332752
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after thr procedure, patient was examined under exploratory hip surgery to remove heterotopic ossification in (b)(6) of this year.The surgery was not extended into the hip capsule and no implants were exchanged.On (b)(6), hip revision was performed for acute trochanteric bursitis.Inflammation of the tissue continuing down to the implant was found.A possible infection is suspected.Head and liner were exchanged, including debridement procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that after thr procedure, patient was examined under exploratory hip surgery to remove heterotopic ossification in january of this year.The surgery was not extended into the hip capsule and no implants were exchanged.On june 15th hip revision was performed for acute trochanteric bursitis, inflammation of the tissue and possible infection.The head and liner were exchanged.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes are but not limited to traumatic injury, joint tightness, material in use, surface finish selection, patient allergy, patient reaction, and loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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 0 DEG XLPE ACET LNR 36MM X 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10259490
• Report Number: 1020279-2020-03062
• Device Sequence Number: 19441158
• Product Code: JDI
• UDI-Device Identifier: 03596010597984
• UDI-Public: 03596010597984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2021

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: Health Professional
• Device Model Number: 71332752
• Device Catalogue Number: 71332752
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 06/19/2021
• 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: Hospitalization; Required Intervention