MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX50MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5560-S-112
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.
Additional Manufacturer Narrative
Additional information: lot number updated and explant date added.An event regarding loosening involving triathlon stem was reported.The reported loosening was not confirmed.Method & results: -device evaluation and results: the stem was returned for evaluation still attached to the femoral component.There is evidence of cement at the junction of the stem and femoral component.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, 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.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated 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.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.

• Brand Name: TRI CEMENTED STEM 12MMX50MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9608668
• Report Number: 0002249697-2020-00143
• Device Sequence Number: 16269351
• Product Code: MBH
• UDI-Device Identifier: 07613327026528
• UDI-Public: 07613327026528
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 12/31/2016
• Device Model Number: 5560-S-112
• Device Catalogue Number: 5560-S-112
• Device Lot Number: M6S58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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: 56 YR
• Patient Weight: 113