MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP DELTA XTEND

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374)

Event Date 02/03/2021

Event Type  Injury  

Event Description

Article entitled ¿reverse shoulder arthroplasty for proximal humeral fractures: better clinical midterm outcome after primary reverse arthroplasty versus secondary reverse arthroplasty after failed orif in the elderly "written by nadine ott, md, kilian wegmann, md, lena george, christian paul, md, and koroush kabir published by sciencedirect on 02/03/2021 was reviewed.This study has analyzed the outcomes of patients with primary reverse arthroplasty and after secondary reverse arthroplasty for failed osteosynthesis.The authors retrospectively reviewed 57 patients with an average age of 76 years from 2010 and 2015 who underwent primary rtsa (30) and secondary rtsa after the failure of plate osteosynthesis (27) after proximal humeral fractures.The functional outcome of the operated shoulder was evaluated by clinical scores, range of motion (rom), pain and activity level.Reverse shoulder arthroplasty is an effective treatment for proximal humeral fractures as primary or revision surgery.The reliable clinical outcome especially in the follow-up to 40 months after primary reverse arthroplasty may suggest to prefer rtsa for complex humeral fractures in the elderly the study looked at rom issues, pain, and activity level.The complications noted during the study included: 1: periprosthetic infection, 1 dislocation.Both were treated with a revision surgery, the implant remained in place open debridement, septic solution and exchange of all mobile components.An exchange of inlay was needed to stabilize the joint.After secondary: periprosthetic infection treated with revision (2), hematoma (1) and a nerve lesion (1).

Manufacturer Narrative

Product complaint # (b)(4).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 CUP DELTA XTEND
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15052752
• MDR Text Key: 296143424
• Report Number: 1818910-2022-13389
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/19/2022

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 SHOULDER HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/26/2022
• 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