MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812130
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/13/2018
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.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional devices listed in this event: catalog: 64812110 description: mrhk femoral bushing, lot: lax155; catalog: 64811140, description: mrh knee fem xl lft, lot: l7kjj; catalog: 64812120, description: mrh axle, lot: lajnp; catalog: 64813113, description: mrh tibial b/plt keel lrg 2, lot: l6sza; catalog: 64812140, description: mrhk tibial sleeve, lot: lah287; catalog: 64813310, description: mrhk tib ins 10mm m/l m2/l2, lot: lax443; catalog: 64812100, description: mrh tib rot comp xs-xl, lot: jb1430; catalog: 64812110, description: mrhk femoral bushing, lot: lau370; catalog: 5560-s-212, description: tri cemented stem 12mmx100mm, lot: n2e05d.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that patient's left knee was revised due to infection (infecting microorganism not identified).9 out of 10 of the devices in an mrh construct were revised (a cemented stem was not revised).

• Brand Name: MRHK BUMPER INSERT - NEUTRAL
• 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: 8153016
• Report Number: 0002249697-2018-03988
• Device Sequence Number: 13895790
• Product Code: KRO
• UDI-Device Identifier: 07613327045260
• UDI-Public: 07613327045260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 11/30/2012
• Device Catalogue Number: 64812130
• Device Lot Number: LAX508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: 52 YR
• Patient Weight: 99