MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 1-2 9MM; PRSTHSS, KN, PTLLFMRTBL, SMCNSTRND, CMNTD, PLY/MTL

Model Number	71453241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to breakage of the ps liner.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation.Our clinical/medical team concluded, reportedly one year following implantation a revision surgery was performed due to breakage of the ps liner.Two intraoperative photos were provided for review, and confirm the reported breakage.Per communication ¿there is no trauma for the patient¿.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.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 complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to articular surface thickness, articular surface condition, and conformity to femur to insert.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN XLPE PS INSERT SZ 1-2 9MM
• Common Device Name: PRSTHSS, KN, PTLLFMRTBL, SMCNSTRND, CMNTD, PLY/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9530473
• Report Number: 1020279-2019-04633
• Device Sequence Number: 2340732
• Product Code: JWH
• UDI-Device Identifier: 00885556255957
• UDI-Public: 00885556255957
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 71453241
• Device Catalogue Number: 71453241
• Device Lot Number: 17DM08151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 10/05/2020
• 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
• Patient Weight: 80