MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PS TIBIAL INSERT TRIAL #5 - 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5532-T-511

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Doctor placed 5x11ps insert onto baseplate for trialing and the insert would not seat down onto baseplate.Doctor removed trial insert and noticed some of the plastic insert was broke and chipped.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert trial was reported.The event was confirmed.Method & results: -device evaluation and results: examination of the returned device with material analysis engineer indicated that overload condition is consistent with reported event.-medical records received and evaluation: not performed as there is no indication the reported event was related to patient factors.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other events for the lot referenced.Conclusions: the returned device confirms the reported event of a fractured trial.The investigation concluded the reported event is the result of a design issue.To address this issue, a design change occurred in 2010 to obsolete this product and create a new replacement product.No further investigation is required at this time.

Event Description

Dr placed 5x11ps insert onto baseplate for trialing and the insert would not seat down onto baseplate.Dr removed trial insert and noticed some of the plastic insert was broke and chipped.

• Brand Name: PS TIBIAL INSERT TRIAL #5 - 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6443528
• MDR Text Key: 71395906
• Report Number: 0002249697-2017-01056
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 5532-T-511
• Device Lot Number: PPM3X47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other