MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM16X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	64786715
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: ti dur reg fluted stem16x155mm; cat# 64786715; lot# t1179.Ti dur reg fluted stem 18x80mm; cat# 64786640; lot# unknown.Mrh tib rot comp xs-xl; cat# 64812100; lot# unknown.Mrhk tib ins 10mm xs/s s1/s2; cat# 64813210; lot# lby029.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Aseptic mobilization of left knee prosthesis with broken stem implanted on 2011.
Event or Problem Description
Aseptic mobilization of left knee prosthesis with broken stem implanted on 2011.
Additional Manufacturer Narrative
The following devices were also listed in this report: ti dur reg fluted stem16x155mm; cat#: 64786715; lot#: t1179.Ti dur reg fluted stem 18x80mm; cat#: 64786640; lot#: unknown.Mrh tib rot comp xs-xl; cat#: 64812100; lot#: unknown.Mrhk tib ins 10mm xs/s s1/s2; cat#: 64813210; lot#: lby029.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding crack/fracture involving a duracon stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TI DUR REG FLUTED STEM16X155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8544202
• Report Number: 0002249697-2019-01694
• Device Sequence Number: 18910141
• Product Code: JWH
• UDI-Device Identifier: 07613327045031
• UDI-Public: 07613327045031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 01/31/2013
• Device Catalogue Number: 64786715
• Device Lot Number: T1179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: 65 YR