MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIAL INSERT SMALL 16MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: gmrs extension piece 80mm; cat#: 64956080; lot#: lbcbi; gmrs small femoral bushing; cat#: 64952105; lot#: unk; gmrs small femoral bushing; cat#: 64952105; lot#: unk; mrhk tibial sleeve; cat#: 64812140; lot#: unk; mrhk bumper insert - neutral; cat#: 64812130; lot#: unk.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
As reported: "no other documents to be provided by physician or hospital.Patient's right knee.Don't have a record of previous surgery date.No trauma cases to patient.Hospital not releasing implants to be returned." rep provided a revision usage sheet with explants hand-written, and a pre-revision x-ray.Update: "patient complained of inability to fully straight leg (lacked full rom of knee)".

• Brand Name: GMRS TIBIAL INSERT SMALL 16MM
• 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: 9513170
• Report Number: 0002249697-2019-04104
• Device Sequence Number: 366358
• Product Code: KRO
• UDI-Device Identifier: 07613327048827
• UDI-Public: 07613327048827
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 64953016
• Device Lot Number: LDK845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/23/2019
• 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: 54 YR