MAUDE Adverse Event Report: STRYKER GMBH SLIDJNG CORE, UHMPWE,8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400142F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device will not be returned.

Event Description

No pain from patient but x-rays showed osteolysis.Patient was revised.

• Brand Name: SLIDJNG CORE, UHMPWE,8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5584097
• MDR Text Key: 42870162
• Report Number: 0008031020-2016-00179
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400142F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR