MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO SIZE 9 CR INSERT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	72120910
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
As reported: "revision of left total knee due to subsided tibial tray".Update 10/04/2018: diagnosis of "marked osteolysis proximal medial tibia with loose tibial component and synovitis".
Event or Problem Description
As reported: "revision of left total knee due to subsided tibial tray".Update 10/04/2018: diagnosis of "marked osteolysis proximal medial tibia with loose tibial component and synovitis".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a scorpio insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: {.} no x-rays are available for review and there is no examination of explanted components.After sixteen years in situ in an obese patient who is post-menopausal, some poly wear with loosening and subsidence of the tibial component is not unexpected.Clinical and past medical history and serial x-rays would be helpful in evaluating this case, as well as examination of the explanted components.It is unlikely that factors associated with component manufacturing or materials were responsible for this late clinical situation.{.} -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot number, clinical and past medical history and serial x-rays operative reports along with return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: SCORPIO SIZE 9 CR INSERT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7936260
• Report Number: 0002249697-2018-03214
• Device Sequence Number: 941279
• Product Code: JWH
• UDI-Device Identifier: 07613327044485
• UDI-Public: 07613327044485
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 72120910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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: 75 YR
• Patient Weight: 123