MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL MED 2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813112
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/05/2018
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.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
It was reported that patient's right knee was revised due to aseptic loosening.Rep reported that x-rays, medical records, and further information beyond that which he provided are not available due to hospital policy.
Event or Problem Description
It was reported that patient's right knee was revised due to aseptic loosening.Rep reported that x-rays, medical records, and further information beyond that which he provided are not available due to hospital policy.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a mrh tibial component was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: review of these records confirms aseptic loosening of a cemented modular rotating hinge tka occurred, however, the root cause cannot be determined as insufficient information was available.Documentation which would aid in the further completion of this assessment would include: operative reports from the revision (b)(6) 2018 surgery, outpatient office/clinic notes, implant retrieval.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.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH TIBIAL B/PLT KEEL MED 2
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7739504
• Report Number: 0002249697-2018-02378
• Device Sequence Number: 13732740
• Product Code: KRO
• UDI-Device Identifier: 07613327045321
• UDI-Public: 07613327045321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 09/18/2018

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: 09/30/2018
• Device Catalogue Number: 64813112
• Device Lot Number: EEJXD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: 68 YR
• Patient Weight: 86