MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH P/S III TIB BEARING INSERT; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	7493-0915
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348)
Date of Event	08/22/2000
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices listed in this event: catalog: 7380-0009l description: modular femoral comp (cement) lot: 93w349.Catalog: 7376-0009 description: cement mod.Tib.W/o holes lot: t00c557.Catalog: 7895-1610 description: series 7000 stem extension lot: 39386401.Catalog: 7895-1655 description: series 7000 stem extension lot: 55739601.Catalog: 6191-1-001 description: simplex p full dose 1 pack lot: rch089.Catalog: 6191-1-001 description simplex p full dose 1 pack lot: rch089.Catalog: 6191-1-001 description: simplex p full dose 1 pack lot: rch092.Catalog: 6191-1-001 description: simplex p full dose 1 pack lot: rdh187.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.
Event or Problem Description
It was reported that, "feels pain in his knee all the time".Update per medical review: after the second stage implantation on (b)(6) 2000 for infection the clinician noted ¿.On (b)(6) 2000 the second-stage revision of the left total knee was performed for which the operative report describes spinal anesthesia and a fifty-six minute tourniquet time.The components inserted were a #9 ts iii femoral component with a 105/16 stem, a #9 ps iii tibia with a 55-millimeter extension, and a is­ millimeter ps iii insert.

• Brand Name: P/S III TIB BEARING INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7903778
• Report Number: 0002249697-2018-03017
• Device Sequence Number: 19191058
• Product Code: JWH
• UDI-Device Identifier: 07613327035582
• UDI-Public: 07613327035582
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K914565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2000
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: 03/31/2005
• Device Catalogue Number: 7493-0915
• Device Lot Number: 52018501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/24/2018
• 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