MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM XS RHT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Insufficient Information (4580)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Device evaluated by manufacturer? not returned.
Event or Problem Description
On (b)(6) 2007, a female patient underwent tka due to osteoarthritis of the knee (right side) caused by rheumatoid arthritis.On (b)(6) 2020 the patient underwent revision surgery due to broke of the implant.It is considered that the wear of polyethylene causes osteolysis, which stresses the implant and causes the stem to break.Cobalt chromium, which normally does not break easily, has broken, so please investigate the cause.
Additional Manufacturer Narrative
Corrected data: lot# an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via evaluation of the returned device.Method & results product evaluation and results: the component was returned fractured at the female threads propagating distally.The fractured fragments from the female threads was returned.A material analysis has been performed.The report concluded: the fracture morphology of the femoral component is consistent with a bending fatigue fracture propagating distally.Damage on the male threads and distal surface of the stem was consistent with contact against the femoral component female threads due to bending.Xrf showed that the femoral component and stem were consistent with their respective drawings.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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.Conclusions: it was reported that the patient's knee was revised due to broke of the implant.Evaluation of the returned device confirmed that the component was fractured at the female threads propagating distally.Material analysis indicated that the fracture morphology of the femoral component is consistent with a bending fatigue fracture propagating distally.Damage on the male threads and distal surface of the stem was consistent with contact against the femoral component female threads due to bending.Xrf showed that the femoral component and stem were consistent with their respective drawings.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
On (b)(6)2007, a female patient underwent tka due to osteoarthritis of the knee (right side) caused by rheumatoid arthritis.On (b)(6)2020 the patient underwent revision surgery due to broke of the implant.It is considered that the wear of polyethylene causes osteolysis, which stresses the implant and causes the stem to break.Cobalt chromium, which normally does not break easily, has broken, so please investigate the cause.

• Brand Name: MRH KNEE FEM XS RHT
• 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: 11223769
• Report Number: 0002249697-2021-00152
• Device Sequence Number: 4422481
• Product Code: KRO
• UDI-Device Identifier: 07613327045123
• UDI-Public: 07613327045123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 04/30/2012
• Device Model Number: 6481-1-101
• Device Catalogue Number: 64811101
• Device Lot Number: SDAPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: 68 YR
• Patient Weight: 64