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

Catalog Number	7115-0004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Injury (2348)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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.Device not returned.
Event or Problem Description
Sales rep reported via the web intake page: tibia implant subsite.Note from cic: event and response to the question is being clarified with the sales rep.Update 09/august/2019 (b)(6): as reported in how was issue noticed "patient walking in pain".Device disposition is listed as 'return to patient' so was likely revised.Update per email received: patient fell on (b)(6) 2019 and was revised on (b)(6) 2019, left side.
Additional Manufacturer Narrative
An event regarding malposition involving a scorpio tibia was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms cemented total knee with tibial component anteriorly tilted, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.X-ray confirms cemented total knee with tibial component anteriorly tilted, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Sales rep reported via the web intake page: tibia implant subsite.Note from cic: event and response to the question is being clarified with the sales rep.Update (b)(6) 2019 wg: as reported in how was issue noticed "patient walking in pain".Device disposition is listed as 'return to patient' so was likely revised.Update per email received: patient fell on (b)(6) 2019 and was revised on (b)(6) 2019, left side.

• Brand Name: SERIES 7000 STANDARD TIBIA
• 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: 8959382
• Report Number: 0002249697-2019-03060
• Device Sequence Number: 16743996
• Product Code: JWH
• UDI-Device Identifier: 07613327033335
• UDI-Public: 07613327033335
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 02/28/2017
• Device Catalogue Number: 7115-0004
• Device Lot Number: MLAPR6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 67 YR