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

Model Number	6481-1-131
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/27/2020
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.
Event or Problem Description
Patient now presents with a fracture of the femoral stem at the junction of the body and requires exchange of femoral and hinge components on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: an event regarding stem crack/fracture involving a mrh femoral component was reported.Conclusions: it was reported that the patient's hip was revised due to a fracture of the femoral stem at the junction of the body.Based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A full investigation is completed on the triathlon stem ((b)(4)) within the same pi.  no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
Patient now presents with a fracture of the femoral stem at the junction of the body and requires exchange of femoral and hinge components on (b)(6) 2020.

• Brand Name: MRH KNEE FEM L RGT
• 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: 11374833
• Report Number: 0002249697-2021-00337
• Device Sequence Number: 17087333
• Product Code: KRO
• UDI-Device Identifier: 07613327045376
• UDI-Public: 07613327045376
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 04/30/2016
• Device Model Number: 6481-1-131
• Device Catalogue Number: 64811131
• Device Lot Number: S3TTL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: 79 YR
• Patient Weight: 127