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

Model Number	400-263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
As reported in clinical investigation, on (b)(6) 2017 an 11mm osteolysis was seen on subject ct scan on the right side located near the medial barrel and medial malleolar.Adverse event onset was about 11 months post-op of a star in her right ankle of (b)(6) 2017.Subject is undergoing observation and event is ongoing without treatment.
Additional Manufacturer Narrative
The reported event that tibial comp, singlecoated us version, large was alleged of issue (osteolysis) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on the available information, no relation could be established between the device and the reported event.The instruction for use clearly states osteolysis and/or other periprosthetic bone loss as one of the potential adverse effects.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported in clinical investigation, on (b)(6) 2017 an 11mm osteolysis was seen on subject ct scan on the right side located near the medial barrel and medial malleolar.Adverse event onset was about 11 months post-op of a star in her right ankle on (b)(6) 2017.Subject is undergoing observation and event is ongoing without treatment.

• 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: 7379609
• Report Number: 0008031020-2018-00246
• Device Sequence Number: 1446264
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: (01)00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 05/31/2020
• Device Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: 1507066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 64