MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURACON CS TIBIA INSERT MED 9; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	67424209
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	05/13/2004
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.The following devices were also listed in this report: dura duration all poly pat med; cat# 6642-2-100; lot# 00084368.Duracon modular non-beaded cr femur asy; cat# 6632-0-525; lot# nveb.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mcl005.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mcl005.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mcl005.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for the right 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: DURACON CS TIBIA INSERT MED 9
• 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: 9086978
• Report Number: 0002249697-2019-03263
• Device Sequence Number: 11397347
• Product Code: MBH
• UDI-Device Identifier: 07613327049497
• UDI-Public: 07613327049497
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 10/31/2008
• Device Catalogue Number: 67424209
• Device Lot Number: LPTA322
• 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: 09/19/2019
• 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: 38 YR
• Patient Weight: 138