MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article abstract entitled, ¿incidence of a stem sitting proud of a proximally coated cementless tapered wedge stem¿ by chul-ho kim, et al; published by journal of orthopaedic translation (2019), vol.19, pp.118-125, was reviewed.The purpose of this study was compare the incidences of a proximally tapered wedge femoral stem seating proud after femoral rasping in 181 trilock bps stems and 157 competitor tapered wedge stems.The authors defined the stem as ¿seating proud¿ if there was a greater than 2 mm mismatch between the final implant and the rasp.The mismatches were corrected by adjusting the offset length of the femoral head.This complaint will capture the results pertaining to the trilock bps stem outlined in table 2 on pp.122.Radiographs are available on page 124 in fig.3.Results: 11 incidences of instrument/implant mismatch.47 cases of intraoperative femoral fracture during stem seating.Treatment was not specified.40 cases of stem positioned in varus.No patient consequences or treatments reported.28 cases stem positioned in valgus.No patient consequences or treatments reported.Captured in this complaint: hip instrument: broach: trial does not replicate implant.Trilock stem: implant malpositioned, fracture.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary
=
> no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

• Brand Name: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10941088
• MDR Text Key: 243499971
• Report Number: 1818910-2020-26067
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1