MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURA DURATION A/P TIB LG 9; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	6642-1-809
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2019
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.
Event or Problem Description
As reported: "(revision due to) wear of tibial bearing component.Stiff knee - left".
Event or Problem Description
As reported: "[revision due to] wear of tibial bearing component.Stiff knee - left".Update on 16 july, 2019: the operative report notes, ¿there was near wear-through both medially and laterally on the tibial plastic¿.The insert was changed to a new ap lipped large 9mm duracon insert and the patellar component was changed to a 36 x3 symmetrical cemented component." the medical review concluded that "after more than twenty-two years in situ with polyethylene inserts available at that time, insert wear is not unexpected.There is no indication this late clinical event was related to factors associated with faulty component design, manufacturing or materials.".
Additional Manufacturer Narrative
An event regarding wear and rom involving a duracon insert was reported.Medical review confirmed wear however there was no confirmation of range of motion issues.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: after more than twenty-two years in situ with polyethylene inserts available at that time, insert wear is not unexpected.There is no indication this late clinical event was related to factors associated with faulty component design, manufacturing or materials.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the medical review concluded the following: after more than twenty-two years in situ with polyethylene inserts available at that time, insert wear is not unexpected.There is no indication this late clinical event was related to factors associated with faulty component design, manufacturing or materials.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DURA DURATION A/P TIB LG 9
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8703828
• Report Number: 0002249697-2019-02272
• Device Sequence Number: 2386439
• Product Code: MBH
• UDI-Device Identifier: 04546540318213
• UDI-Public: 04546540318213
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• 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): 08/14/2019

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: Health Professional
• Device Catalogue Number: 6642-1-809
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: 82 YR
• Patient Weight: 213