MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-409

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been one other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that upon opening the implant, it was noted that there were rivets and dents in the insert.It was reported that the implant appeared damaged.It was reported that a second implant was opened and used for the patient.

Manufacturer Narrative

An event regarding damage involving a triathlon insert was reported.The event was confirmed.Device evaluation and results: material analysis of returned device was performed and indicated that "the damages observed on the tibial insert were consistent with multiple impacts likely with the stabilizing post.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: it was reported that upon opening the implant it was noted that there were rivets and dents in the insert.The reported event confirmed on the basis of visual inspection and material analysis report.The material analysis engineer indicated that damage observed aon the tibial insert were consistent with multiple impacts likely with the stabilizing post.No further investigation is possible at this time , if further information becomes available this investigation will be re-opened.

Event Description

It was reported that upon opening the implant, it was noted that there were rivets and dents in the insert.It was reported that the implant appeared damaged.It was reported that a second implant was opened and used for the patient.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6923214
• MDR Text Key: 89540690
• Report Number: 0002249697-2017-02931
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2018
• Device Catalogue Number: 5537-G-409
• Device Lot Number: MMAMAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2013
• 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): Other