MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIAL INSERT SMALL 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: gmrs proximal tib sml; cat# 64953101; lot# 034732c, gmrs small axle; cat# 64952115; lot# ctd20592, gmrs small femoral bushing; cat# 64952105; lot# lhb045, gmrs small femoral bushing; cat# 64952105; lot# lex203, gmrs tib rotating sml comp; cat# 64953601; lot# 110398, gmrs dist fem comp sml l 65 mm; cat# 64952010; lot# ec3xf, mrhk bumper insert - neutral; cat# 64812130; lot# lha158, gmrs tibial insert small 10 mm; cat# 64953010; lot# lfh112.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the sterile lot referenced.Not available.
Event or Problem Description
It was reported that patient's left knee was revised due to infection (unknown if clinically confirmed or identified).
Additional Manufacturer Narrative
Additional information: pma/510(k)#; manufacturing date.Corrected data: expiration date.An event regarding infection involving a gmrs insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were provided for review.-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 lot or sterile lot referenced.Conclusion: the event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as product return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's left knee was revised due to infection (unknown if clinically confirmed or identified).

• Brand Name: GMRS TIBIAL INSERT SMALL 10MM
• 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: 7548410
• Report Number: 0002249697-2018-01595
• Device Sequence Number: 19276360
• Product Code: KRO
• UDI-Device Identifier: 07613327048810
• UDI-Public: 07613327048810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 09/30/2021
• Device Catalogue Number: 64953010
• Device Lot Number: LFH112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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: 59 YR
• Patient Weight: 43