MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	72-13-0908
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	06/12/2012
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.Not returned.
Event or Problem Description
It was reported by the patient to the legal department via telephone that following his right knee surgery he began experiencing clicking, felt movement and felt like his right knee was loose.He was revised on (b)(6) 2012.Update per medical review: ¿on (b)(6) 2012 revision of the right total knee, femur, and poly exchange was performed for a post-operative diagnosis of aseptic loosening with osteolysis of the femoral component.The operative report describes spinal anesthesia and a tourniquet time of fifty-five minutes.The operative report notes, "synovium had the look of osteolysis".The femoral component was grossly loose and easily removed.The poly showed evidence of cement abrasion and wear of poly post.The femoral cement was removed and the canal was prepared for revision components.¿.
Event or Problem Description
It was reported by the patient to the legal department via telephone that following his right knee surgery he began experiencing clicking, felt movement and felt like his right knee was loose.He was revised on (b)(6)2012.Update per medical review: ¿on (b)(6)2012 revision of the right total knee, femur, and poly exchange was performed for a post-operative diagnosis of aseptic loosening with osteolysis of the femoral component.The operative report describes spinal anesthesia and a tourniquet time of fifty-five minutes.The operative report notes, "synovium had the look of osteolysis".The femoral component was grossly loose and easily removed.The poly showed evidence of cement abrasion and wear of poly post.The femoral cement was removed and the canal was prepared for revision components.¿.
Additional Manufacturer Narrative
An event regarding osteolysis involving a scorpio insert was reported.The event was not 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 osteolysis was not confirmed nor the root cause determined based on the clinician¿s findings in the medical review.It was noted by the clinician, ¿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.¿.

• Brand Name: SCORPIO TOTAL KNEE PS TIBIAL 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: 7680527
• Report Number: 0002249697-2018-02145
• Device Sequence Number: 1528225
• Product Code: JWH
• UDI-Device Identifier: 07613153992592
• UDI-Public: 07613153992592
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• 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: 12/31/2012
• Device Catalogue Number: 72-13-0908
• Device Lot Number: 25216601
• 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: 73