MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIB ROT COMP XS-XL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-2-100
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding damage involving an mrh tibial component was reported.The event was confirmed by mar review.Method & results: device evaluation and results: visual inspection indicated that damage on the proximal surface of the tibial rotating component likely occurred from contact with the femoral component.Scratching on the proximal and distal surfaces of the tibial rotating component is consistent with damage from explantation.A material analysis report concluded: damage was observed on the axle and tibial rotating component, consistent with in-service use.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.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.Conclusions: it was reported that the patient was revised due to wear of the poly components however the reported mrh tibial component was also revised.A material analysis report concluded: damage was observed on the axle and tibial rotating component, consistent with in-service use.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be released by the hospital or surgeon.

• Brand Name: MRH TIB ROT COMP XS-XL
• 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: 8905516
• Report Number: 0002249697-2019-02883
• Device Sequence Number: 2731197
• Product Code: KRO
• UDI-Device Identifier: 07613327045208
• UDI-Public: 07613327045208
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/27/2020

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 Model Number: 6481-2-100
• Device Catalogue Number: 64812100
• Device Lot Number: 022702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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: 25 YR