MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1100-40-000

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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.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.

Event Description

It was reported that the surgeon told sales rep in the am on (b)(6) 2022 he was revising a patient hemi arthroplasty that afternoon and asked him to look at x-rays.He told him it appeared to be a unite stem construct and that he would be able to convert to a reverse construct if he would like.Surgeon was revising this construct because of cuff deficiency which was causing lack of rom and pain.He explanted the unite proximal body, the humeral head and converted the construct to a reverse shoulder.The unite stem was left in situ.The original date of surgery and who did the surgery was unknown.Doi: unknown.Dor: (b)(6) 2022.Affected side: right shoulder.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 12
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15494824
• MDR Text Key: 300697561
• Report Number: 1818910-2022-18831
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004417
• UDI-Public: 10603295004417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170748
• 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
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-40-000
• Device Catalogue Number: 110040000
• Device Lot Number: TH13725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• 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
• Treatment: GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 44X15 STD
• Patient Outcome(s): Required Intervention
• Patient Sex: Female