MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH; UNK HIP INSTRUMENT

Catalog Number UNK BROACH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/04/2020

Event Type  Injury  

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 entitled, ¿absence of instabilities and intra-prosthetic dislocations at 7 to 11 years following tha using a fourth-generation cementless dual mobility acetabular cup¿ by julien chouteau, et al, published by journal of experimental orthopaedics (2020), vol.7, no.51, https://doi.Org/10.1186/s40634-020-00265-3, 8 pages.Was reviewed.The purpose of this study was o review revision rated for the serf novae sunfit th dual mobility acetabular cup in 240 tha implanted between june 2007 and june 2010.The serf cups were paired with a corail stem and an unknown ceramic femoral head, assumed to be a depuy product.Depuy products used in the study: corail stem, serf novae sunfit tm dual mobility cup and polyethylene liner, unknown ceramic femoral head, corail femoral broach results: revisions and complications: 2 total revisions to treat deep infection.2 isolated liner revision to treat deep infections.1 total revision to treat periprosthetic femoral fracture secondary to unspecified trauma.1 isolated stem revision to treat loosening at the bone to implant interface.2 deep infections treated with irrigation and debridement.3 cases of iliopsoas impingement ¿ no treatment specified.12 cases of intraoperative femoral fracture during broaching treated with cerclage.Fig.3 on page 4 provides a photographic example of the intraoperative femoral crack.Radiographic results identified on serial radiographic studies: 21 cases of heterotopic ossification - no treatment provided.25 cases of radiolucent lined around the stem - no treatment provided.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.Product/lot information is unknown.Examination of an intra-operative photograph confirms a femoral bone fracture while the broach is fully seated within the femoral canal.It is not possible to conclude there was any error in manufacture or material with the information available.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNK BROACH
• Type of Device: UNK HIP INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11048797
• MDR Text Key: 223144857
• Report Number: 1818910-2020-27374
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention