MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL HEAD CTA/CAP

Catalog Number UNK HUMERAL HEAD CTA/

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 02/27/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: tøttrup m, thillemann jk, thillemann tm, mechlenburg i, klebe t, søballe k, stilling m.Early offset-increasing migration predicts later revision for humeral head resurfacing implants.A randomized controlled radiostereometry trial with 10-year clinical follow-up.J orthop res.2022 feb 27.Doi: 10.1002/jor.25298.Epub ahead of print.Pmid: (b)(6).Objective and methods: the specific aims of this long-term follow-up study were contrast the medium to long-term outcomes of the depuy global cap shoulder hemiarthroplasty with a competitor shoulder construct (1) to compare implant migration at 5-year follow-up, (2) to compare clinical outcomes at 5 years and at 9¿13 years follow-up and (3) to evaluate if implant migration, changes in offset and changes in humeral head inclination were related to increased risk of implant revision.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: global cap hemiarthroplasty adverse event(s) and provided interventions associated with depuy devices: 13 migrations identified radiographically.An unknown number of these were revised.7 revisions of the global cap and 8 revisions of the competitor device.The authors do not provide the reasons for revision specific to each device manufacturer.The actual number of depuy devices associated with each event is unknown.Reasons for revisions: glenoid wear (captured as bone injury as the glenoid was not resurfaced) device migration; pain; periprosthetic fracture; rotator cuff tear; anterior subluxation (captured as joint instability); one intraoperative finding of inadequate osseointegration without loosening of the device.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER HUMERAL HEAD CTA/CAP
• Type of Device: SHOULDER HUMERAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14776087
• MDR Text Key: 295033537
• Report Number: 1818910-2022-11482
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HUMERAL HEAD CTA/
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• 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