MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64813210

Device Problem Naturally Worn (2988)

Patient Problem Injury (2348)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that patient's right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.

Event Description

It was reported that patients right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.

Manufacturer Narrative

An event regarding wear involving a mrh insert was reported.The event was confirmed based on evaluation of the returned device.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report mar, dated 31-oct-2019.The devices were examined with the aid of a stereo microscope at magnifications up to 50x.This inspection indicated that scratching, burnishing, and third body indentations were observed on the proximal surface of the tibial insert; these are common damage modes of uhmwpe.Impression markings were observed on the distal surface of the insert consistent with contact against the baseplate.Damage consistent with the explantation process was observed on the distal and anterior surface.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: based on the ma review, scratching, burnishing, and third body indentations were observed on the proximal surface of the tibial insert; these are common damage modes of uhmwpe.Impression markings were observed on the distal surface of the insert consistent with contact against the baseplate damage consistent with the explantation process was observed on the distal and anterior surface.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, and additional serial dated x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRHK TIB INS 10MM XS/S S1/S2
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9238824
• MDR Text Key: 164298464
• Report Number: 0002249697-2019-03609
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (y/n): N
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64813210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 52