MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURA DURATION A/P TIB LG 11; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	6642-1-811
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Ambulation or Postural Difficulties (2544)
Date of Event	10/16/2003
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
This pi is for the left knee.Patient called stating she had bilateral knee replacements done.She reported pain, swelling, difficulty walking and discomfort.Patient would like to know if her implants are part of a recall.

• Brand Name: DURA DURATION A/P TIB LG 11
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9082271
• Report Number: 0002249697-2019-03245
• Device Sequence Number: 11463718
• Product Code: MBH
• UDI-Device Identifier: 04546540318220
• UDI-Public: 04546540318220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: Health Professional
• Device Expiration Date: 07/31/2008
• Device Catalogue Number: 6642-1-811
• Device Lot Number: 06276601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: Other
• Patient Age: 37 YR
• Patient Weight: 138