MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	04/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced an infection.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The 20 deg xlpe acet lnr 32mm x 50mm was explanted.During washout + calcium sulphate beads procedure the 3 hole ha ctd acet shell 50mm appeared loose, with osteolysis also seen superolateral in the acetabulum/ilium.The cocr 12/14 fem head 32 + 0 and two unidentified screws were also explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical medical was not performed due to the requested surgical records and x-rays being unavailable.Without the requested surgical records and x-rays, the clinical root cause of the infection cannot be concluded.The patient impact beyond the revision cannot be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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 20 DEG XLPE ACET LNR 32MM X 50MM
• 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: 11821275
• Report Number: 1020279-2021-04254
• Device Sequence Number: 14330147
• Product Code: JDI
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 71337650
• Device Catalogue Number: 71337650
• Device Lot Number: 20HM06375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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