MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE STEM

Catalog Number UNK KNEE STEM

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that while performing a revision knee fusion on the patient, the surgeon removed the old cemented component and decided to implant a press fit component.After removing all traces of the previously implanted cement, the surgeon reamed the femoral canal first with flexible im reamers to the desired size, 15mm.Then, the surgeon reamed with sequential aml straight reamers.Because the patient had less than desired bone density, the surgeon choose to ream line to line of the implant size chosen.The surgeon reamed to a 15.5 and choose to implant a 15.5x125mm stem.Here is the problem, the surgeon was able to stick the component in and pull it out easily with his finger.This being unacceptable and confusing to say the least, the surgeon had to choose the next size larger stem and insert this stem.This stem, 16.5mm, was implanted properly with the use of an impaction handle and mallet.Because this component fit properly, the surgeon was able to proceed and lock the tibial and femoral component together with new intracalry section and segmental components.The patient was closed in the usual fashion.Because of the confusion as to why this stem did not fit, at the end of the procedure, the sales rep used a caliper and measured the largest flexible reamer head used, 15mm, the largest straight aml reamer used 15.5mm.Then, he measured the wasted stem 15.5.It was also reported that there was non-cemented loosening of the lps 15.5 porous stem.Surgical delay was unknown.Doi: unknown.Dor: (b)(6) 2024.Affected side : right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK KNEE STEM
• Type of Device: KNEE STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19143496
• MDR Text Key: 340598087
• Report Number: 1818910-2024-08659
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female