MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-411

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Surgeon noticed a "fray" on a 4x11mm ps poly.We did not implant it.It is available to send in.Right side.

Event Description

Surgeon noticed a "fray" on a 4x11mm ps poly.We did not implant it.It is available to send in.Right side.

Manufacturer Narrative

An event regarding an appearance issue (fray) involving a triathlon insert was reported.The reported lines were visible however the product was confirmed to be visually within specification.Method & results: device evaluation and results: the insert was returned for evaluation, while a slight inconsistent edge is noticed on the posterior of the condyle, the implant was visually inspected by operators trained to the inspection of tibial inserts.The ¿fray¿ was not able to be verified through standard visual inspection methods per the requirements set forth in (b)(4) during this investigation.No other visual defects which may constitute a ¿fray¿ or burr could be observed.See memo for further detail.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the product manufacturing cell representative completed a thorough evaluation of the returned device which indicated the following: the complaint was opened for a ¿fray¿ that a surgeon noticed prior to implantation.From the device history record (dhr) of this lot, it can be shown that the lot was machined at stryker integrated manufacturing in kalamazoo under the poly subcomponent p/n and identical lot id of 9532-g-411 / 99044018, respectively.The lot was received in the tibial plastics cell at stryker mahwah where it underwent vendor inspection with wire insertion and subsequently final cleaning, packaging and sterilization steps.Specifically, at the vendor inspection/assembly operation, the operator would have visually inspected all pieces and then performed wire insertion in accordance with procedures (b)(4), manual wire assembly procedure for uhmwpe tibial bearings and (b)(4), procedure for appearance screening of uhmwpe implants.It is at this operation where operators would inspect for burrs (frays) which may have been created during the machining process at kalamazoo and perform deburring, if required, to ensure conformance of the implant to (b)(4).After the unit from the complaint was returned, the implant was visually inspected by operators trained to the inspection of tibial inserts.The ¿fray¿ was not able to be verified through standard visual inspection methods per the requirements set forth in (b)(4) during this investigation.No other visual defects which may constitute a ¿fray¿ or burr could be observed.Dynamic control plan (dcp) (b)(4) which governs this product line and operation describes the potential occurrence of excess burrs at a rate of 1, corresponding to (b)(4) units for kalamazoo machined implants.This occurrence rate has not been exceeded through the existence, if any, of previous complaints for similar issues.Thus, with the visual defect being unable to be confirmed coupled with the occurrence rate of the defect below the specified threshold within the dcp, a nc is not warranted for complaint.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8595964
• MDR Text Key: 144581959
• Report Number: 0002249697-2019-01905
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 5532-G-411
• Device Lot Number: 99044018C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 57