MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	7115-0009
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported by the patient to the legal department via telephone that following his left knee surgery, he experienced a bowed leg effect, pain and swelling.He had a complete revision on (b)(6) 2014 and as per dr.(b)(6), his knee "failed catastrophically".Left knee.Update per medical review: ¿on (b)(6) 2014 a revision of the left total knee arthroplasty was performed for a diagnosis of "failed left tka".The operative report describes the use of a tourniquet and notes, "femoral component clearly loose, tibia loose and punched out easily.Debrided granulomatous tissue.Substantial bone loss, cystic area scraped out." a zimmer cone for the tibial was prepared with a midis rex to allow for a #8 triathlon tibial baseplate with a 15mm stem and a 10mm full block augment.A #7 ts femoral component with a 15mm distal augment, a 10mm.Posterior augment and a medium zimmer cone was utilized.A #8/11 ts insert was placed in the tibia uncomplicated surgery was described and the patient was discharged on (b)(6) 2014.Surgical pathology final diagnosis was "foreign body giant cell reaction to cement material consistent with failed joint prosthesis".¿.
Additional Manufacturer Narrative
An event regarding subsidence involving a scorpio baseplate was reported.The event was confirmed by medical review method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿there is no examination of the explanted components and no radiographic evidence of loosening or osteolysis except for the (b)(6)2014 film of the left knee demonstrating medial tibial subsidence.The description of "cement abrasion" on the poly noted on the (b)(6)2012 right knee revision operative report suggests degenerating poly particles, which could explain the osteolysis described.The explanted components were not received therefore poly wear could not be confirmed.The surgical pathology report from (b)(6)2014 of the left knee revision noted, "giant cell reaction to cement mantel".In this male patient after five years in situ, the slight genu varum may have contributed to the failure and fragmentation of the cement mantle resulting in the findings described at surgery in the left knee revision.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.¿ -product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event for subsidence was confirmed by the medical review.The clinician noted that on (b)(6)2014 film of the left knee showed medial tibial subsidence.The clinician stated, ¿the surgical pathology report from (b)(6)2014 of the left knee revision noted, "giant cell reaction to cement mantel".In this male patient after five years in situ, the slight genu varum may have contributed to the failure and fragmentation of the cement mantle resulting in the findings described at surgery in the left knee revision.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.¿.
Event or Problem Description
It was reported by the patient to the legal department via telephone that following his left knee surgery he experienced a bowed leg effect, pain and swelling.He had a complete revision on (b)(6)2014 and as per dr.Markel his knee "failed catastrophically".Left knee update per medical review: ¿on (b)(6)2014 a revision of the left total knee arthroplasty was performed for a diagnosis of "failed left tka".The operative report describes the use of a tourniquet and notes, "femoral component clearly loose, tibia loose and punched out easily.Debrided granulomatous tissue.Substantial bone loss, cystic area scraped out." a zimmer cone for the tibial was prepared with a midis rex to allow for a #8 triathlon tibial baseplate with a 15mm stem and a 10mm full block augment.A #7 ts femoral component with a 15mm distal augment, a 10mm.Posterior augment and a medium zimmer cone was utilized.A #8/11 ts insert was placed in the tibia uncomplicated surgery was described and the patient was discharged on december 31, 2014.Surgical pathology final diagnosis was "foreign body giant cell reaction to cement material consistent with failed joint prosthesis".¿.

• Brand Name: SERIES 7000 STANDARD TIBIA
• 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: 7680523
• Report Number: 0002249697-2018-02144
• Device Sequence Number: 10923990
• Product Code: JWH
• UDI-Device Identifier: 07613327033373
• UDI-Public: 07613327033373
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 09/30/2014
• Device Catalogue Number: 7115-0009
• Device Lot Number: MHM93V
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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: 65 YR
• Patient Weight: 78