MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI LM/RL TIB AUG SZ5 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5545-A-501
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
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 lot referenced.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.
Event or Problem Description
In the surgery performed on (b)(6) 2018, at the end of the procedure to open a tibial increase of 5x5 mm lateral / right, the implant does not block when trying to make the closure.This is the reason by which the surgeon decided to fill with cement so as not to prolong the surgical time, which started at 5:55 pm and when cementing was 20:20.The wedge in reference is 5545-a-501 and lot ereal5d.
Event or Problem Description
In the surgery performed on (b)(6) 2018, at the end of the procedure to open a tibial increase of 5x5 mm lateral / right, the implant does not block when trying to make the closure.This is the reason by which the surgeon decided to fill with cement so as not to prolong the surgical time, which started at 5:55 pm and when cementing was 20:20.The wedge in reference is (b)(4) and lot ereal5d.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a triathlon augment was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned with no remarkable scratches observed.A functional inspection was performed on the returned triathlon augment with a triathlon baseplate (cat 5521-b-500, lot ao34ba) from finished goods.It was verified that the pin from the augment were engaged into the slots on the underside of the baseplate and the augment was seated flush.The returned augment was found to be functionally acceptable.See attached pictures.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event is not confirmed.The returned device was found to be functionally acceptable when mated with the same sized triathlon baseplate from finished goods.There are no remarkable damages observed on the returned part.No further investigation is needed at this time.If additional information becomes available, this investigation will be reopened.

• Brand Name: TRI LM/RL TIB AUG SZ5 5MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8418059
• Report Number: 0002249697-2019-01311
• Device Sequence Number: 11224192
• Product Code: MBH
• UDI-Device Identifier: 07613327026382
• UDI-Public: 07613327026382
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 07/31/2022
• Device Catalogue Number: 5545-A-501
• Device Lot Number: EREAL5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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: Other