MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM PS HF INSERT SZ 3-4 9MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71422667
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after eight months of surgery, a revision was performed due to the insert that dislocated without trauma and was found damaged.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The device was manufactured in 2017.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.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical/medical team noted: this complaint from india reports the revision of a knee secondary to ¿dislocation and damaged insert¿.This pain occurred eight months post implantation.The revision was performed ten months post implantation.No trauma was reported that could have contributed to the dislocation.A picture of the damaged insert was provided, the picture reveals the damage however, does not reveal an indication of what caused the dislocation.The impact to the patient beyond the additional surgery and recovery cannot be determined.It was not reported if a change is insert size was made in the revision.In conclusion, the root cause of the dislocation that precipitated the revision cannot be concluded with the available information.

• Brand Name: ANTHEM PS HF INSERT SZ 3-4 9MM
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720228
• Report Number: 1020279-2020-00602
• Device Sequence Number: 2352798
• Product Code: JWH
• UDI-Device Identifier: 00885556583944
• UDI-Public: 00885556583944
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 71422667
• Device Catalogue Number: 71422667
• Device Lot Number: 17EM13404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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 Age: 71 YR