MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURDURT TS TIB INS LG 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	6642-5-311
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported that the patient's right knee was revised due to excessive insert wear.Surgeon reported contributing factors: implanted for 14 years, and patient weight gain of over 200 pounds.A large duracon 11mm insert was revised to a large duracon 28mm insert.Rep provided the primary operative report, pre-revision x-ray, revision implant sheet, and device pictures and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding wear involving a duracon insert was reported.The event was confirmed based on the images provided.Method & results: -device evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted insert.Blood and explantation damage is visible on the insert with wear visible along the lateral compartment (right knee).Some of the photographs show the insert with the stabilizer support bracket attached and some photographs show the insert with the support bracket removed.-medical records received and evaluation: a review of the provided medical records was rejected for medical review by a clinical consultant who stated the following comment: need revision operative report and serial x-rays.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: while the wear on the component could be confirmed through review of the provided photographs, the exact cause of the event could not be confirmed.It is noted that the implant had been in situ and it is also reported that the patient had gained over 200 pounds since primary surgery however, additional information including revision operative report, serial x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right knee was revised due to excessive insert wear.Surgeon reported contributing factors: implanted for 14 years, and patient weight gain of over 200 pounds.A large duracon 11mm insert was revised to a large duracon 28mm insert.Rep provided the primary operative report, pre-revision x-ray, revision implant sheet, and device pictures and reported that no further information will be available.

• Brand Name: DURDURT TS TIB INS LG 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8304872
• Report Number: 0002249697-2019-00483
• Device Sequence Number: 62175
• Product Code: JWH
• UDI-Device Identifier: 04546540318916
• UDI-Public: 04546540318916
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: No Information
• Device Catalogue Number: 6642-5-311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: 60 YR