MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-2-130
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2020
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 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.Catalog numbers and lot codes of other devices listed in this report: 64812140, mrhk tibial sleeve, lot lcl758.64952105, gmrs small femoral bushing, lot lcw343.64952105, gmrs small femoral bushing, lot lcn680.64813210, mrhk tib ins 10mm xs/s s1/s2, lot lcs554.64952115, gmrs small axle, lot ctd777.64812100, mrh tib rot comp xs-xl, lot 023234.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "patient had pain.X-rays showed potential damage to bumper and bushings.Surgeon performed poly swap to exchange the sleeve, insert, rotating component, two bushings, axle and bumper." right side.Spoke to rep, who provided a picture of the explants and x-rays.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding damage involving a mrh bumper was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - the reported device was not returned however photographs were provided for review.The photographs show a recently explanted device with damage appeared on its surface.It is uncertain whether it an explantation damage or in situ damage.Clinical review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: - no clinical or pmh, no serial, dated x-rays, no operative reports, no listing of components or examination of explanted components.Based upon the 2 x-rays provided, neither confirmation of the event description nor preparation of a medical report is possible for this case.Product history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: an event regarding damage involving a mrh bumper was reported.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as medical documentation, patient history, demographics are needed.If additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
As reported: "patient had pain.X-rays showed potential damage to bumper and bushings.Surgeon performed poly swap to exchange the sleeve, insert, rotating component, two bushings, axle and bumper." right side.Spoke to rep, who provided a picture of the explants and x-rays.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MRHK BUMPER INSERT - NEUTRAL
• 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: 10987632
• Report Number: 0002249697-2020-02636
• Device Sequence Number: 16300907
• Product Code: KRO
• UDI-Device Identifier: 07613327045260
• UDI-Public: 07613327045260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 08/31/2016
• Device Model Number: 6481-2-130
• Device Catalogue Number: 64812130
• Device Lot Number: LCO137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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: 22 YR
• Patient Weight: 130