MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERSION, LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Model Number	400-263
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Tibial revision and poly exchange.
Additional Manufacturer Narrative
The reported event that tibial comp,singlecoated us version, large was alleged of tibial revision and poly exchange could be confirmed.The device inspection revealed the following: the pe sliding core shows various signs of wear, such that it is trimmed on one of its lateral sides and scratched in several areas.This was likely produced by the articulation with the talar component.The tibial component showed signs of use in the form of scratches, but no significant damage.Some bone residues are still attached to the returned device, proving that osteo-integration happened between the bone and the implant.Overall the results of the stage 1 analysis are consistent with well-positioned and well-functioning devices implanted for approximately 3.5 years.For this case, since some radiographs of the implanted patient were returned, the medical opinion of stryker's medical expert was requested.Their statement is the following: " i have reviewed the implant, report and radiographs.The surgeon [of the procedure] feels the need for removal was the thinning of the poly, as seen this is not the case.What is apparent is the subsidence of the talar component.Subsidence of the talar component in star is of major concern and if left untreated will affect the stability of the ankle joint, leaving it prone to shortening, varus, valgus or translation on the sagittal plane.It certainly appears from the radiographs of 10/31/17 that the talar component has subsided into the talus.The choice to remove the poly and the review of the explanted poly, does not seem reasonable.This scenario is not directly related to the star implant." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Tibial revision and poly exchange.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7379612
• Report Number: 0008031020-2018-00248
• Device Sequence Number: 1393550
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: (01)00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: 1424004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 86