MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS EXTENSION PIECE 50MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64956050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported lot.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.
Event or Problem Description
Explantation was necessary because of a fissure of the distal femur.During explantation, the inner bushing loosened from the gmrs extension piece.Extension was coated in (b)(6) 2017.New extension was used to complete the procedure successfully.
Event or Problem Description
Explantation was necessary because of a fissure of the distal femur.During explantation, the inner bushing loosened from the gmrs extension piece.Extension was coated in (b)(6) 2017.New extension was used to complete the procedure successfully.
Additional Manufacturer Narrative
An event regarding a disassembly issue involving a gmrs extension piece was reported.The event was confirmed through photographs.Conclusions: during a revision procedure for fissure, a disassembly issue occurred, whereby the sleeve of an extension piece became lodged on the extension piece in this investigation.The exact cause of the event could not be determined based on the information provided.Further information such as device evaluation, pre- and post-operative x-rays and the primary operative report as well as patient details, history and follow-up notes are needed to complete the investigation for determining root cause.If the devices and/or additional information become available, this investigation will be reopened and re-evaluated.

• Brand Name: GMRS EXTENSION PIECE 50MM
• 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: 7300580
• Report Number: 0002249697-2018-00562
• Device Sequence Number: 2116706
• Product Code: KRO
• UDI-Device Identifier: 07613327049220
• UDI-Public: 07613327049220
• Combination Product (Y/N): N
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 64956050
• Device Lot Number: BLN2D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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: Other