MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: case-(b)(4).
Event or Problem Description
It was reported that revision surgery was scheduled to potentially remove and replace acetabular cup and liner due to suspected loosening due to lysis.Upon inspection the cup was well fixed and a cyst was found under a section of the cup.This was excised and bone graft placed through the hole in the cup.A new liner and femoral head were put in place and the wound closed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that revision surgery was scheduled to potentially remove and replace acetabular cup and liner due to suspected loosening secondary to lysis.However, upon inspection, there was a cyst found under the well-fixed cup which was reportedly excised and filled with bone graft along with implantation of a new liner and head.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes 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 complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that medical documentation would not be provided due to lack of consent.Based on the information provided, the root cause of the revision was the cystic formation under the cup which was believed to be loosening/lysis; however, the cause of the cyst could not be concluded.The patient impact beyond the reported findings and interventions could not be determined, as no injury was reported.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• 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: 11095661
• Report Number: 1020279-2020-08036
• Device Sequence Number: 17068466
• Product Code: JDI
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: 71335754
• Device Catalogue Number: 71335754
• Device Lot Number: 13KM17921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 05/17/2021
• 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