MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PS TIBIAL INSERT TRIAL #4 - 16MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5532-T-416

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Surgeon was hitting insert with mallet size 4 ps tibial trial insert into joint with both the femoral knee implant and tibial implant cemented in place, when a piece of the posterior tibial trial insert broke.

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 the fracture is consistent with overload condition.-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

Surgeon was hitting insert with mallet size 4 ps tibial trial insert into joint with both the femoral knee implant and tibial implant cemented in place, when a piece of the posterior tibial trial insert broke.

• Brand Name: PS TIBIAL INSERT TRIAL #4 - 16MM
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6371710
• MDR Text Key: 69159482
• Report Number: 0002249697-2017-00749
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

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-416
• Device Lot Number: SMCYH19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2005
• 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
• Patient Age: 55 YR
• Patient Weight: 95