MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 23X80MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	64786665
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
After implant was removed, it was noticed that the stem was lose and the was a crack on the connection between stem and femur component.
Event or Problem Description
After implant was removed, it was noticed that the stem was lose and the was a crack on the connection between stem and femur component.
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a duracon stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices was performed.The stem extender component was returned assembled to the mrh femoral component.The stem extender was unscrewed from the mrh femoral component as part of the evaluation.The mrh femoral component is consistent with an explanted device.There are nicks and scratches on the component, most likely from in vivo use and subsequent explantation.There is no obvious damage to the component.There is no damage evident on the mrh femoral boss/thread.Dimensional inspection was not performed as the dimensional aspects are not in question- based on the manufacturing date of the device it would have been implanted in this very active patient for at least 10 years.Medical records received and evaluation: not performed as no medical records were received for review.Product history review: indicated 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 lot referenced.Conclusion: the stem extender component was returned assembled to the mrh femoral component.The stem extender was unscrewed from the mrh femoral component as part of the evaluation.The mrh femoral component is consistent with an explanted device.There are nicks and scratches on the component, most likely from in vivo use and subsequent explantation.There is no obvious damage to the component.There is no damage evident on the mrh femoral boss/thread.Dimensional inspection was not performed as the dimensional aspects are not in question- based on the manufacturing date of the device it would have been implanted in this very active patient for at least 10 years.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, patient history and x-rays 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: TI DUR REG FLUTED STEM 23X80MM
• 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: 7682072
• Report Number: 0002249697-2018-02149
• Device Sequence Number: 848073
• Product Code: JWH
• UDI-Device Identifier: 07613327044973
• UDI-Public: 07613327044973
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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 Catalogue Number: 64786665
• Device Lot Number: TBYC91A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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