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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1818910-2022-04107
• Device Sequence Number: 4996404
• Product Code: HSD
• UDI-Device Identifier: 10603295004639
• UDI-Public: 10603295004639
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK ANCHOR PG GLENOID 52; GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE HEAD 48X18 ECC; UNK SHOULDER STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male