MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1100-50-000

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

Patient Problems Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535)

Event Date 02/17/2022

Event Type  Injury  

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.

Event Description

It was reported that the patient had his shoulder replaced by surgeon sometime ago.The patient had a global unite construct implanted.The patient did well initially but injured his rotator cuff and lost rom over time.It was decided that surgeon would convert the anatomic construct to a reverse construct.The apg , humeral head, and proximal body were explanted during the revision surgery.The stem was left in situ and a delta reverse construct was implanted.The original implant date is unknown.There was no surgical delay.Doi: unknown; dor: (b)(6) 2022; affected side: left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received indicates "the event was due to natural progression" it is reasonable to conclude that the device reported on this medwatch would not cause or contribute to the reported serious injury/revision as the revision is the consequence of natural, ongoing degenerative disease running its course, and not a consequence of the global unite products or procedure.At this time depuy synthese joint reconstruction considers the device on this report to be not reportable.Not reportable.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 14
• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13667197
• MDR Text Key: 286575654
• Report Number: 1818910-2022-04107
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004639
• UDI-Public: 10603295004639
• 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,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-50-000
• Device Catalogue Number: 110050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• 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: CROSSLINK ANCHOR PG GLENOID 52; GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE HEAD 48X18 ECC; UNK SHOULDER STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male