MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HUMERAL HEAD SIZE 46; SHOULDER HUMERAL HEADS

Catalog Number	114020046
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Muscle/Tendon Damage (4532)
Date of Event	06/08/2020
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
Clinical adverse event received for biceps tendonitis after tenodesis.Event is not serious and is considered mild.Event is possibly related to device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (right shoulder).Treatment: medical intervention/modification (details unspecified).
Additional Manufacturer Narrative
Product complaint # (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.Device history lot: dhr was reviewed.1) quantity manufactured: (b)(4).2) date of manufacture: 18-dec-2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30-nov-2027.5) ifu reference: 1140-20-046.

• Brand Name: HUMERAL HEAD SIZE 46
• Common Device Name: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12283042
• Report Number: 1818910-2021-17189
• Device Sequence Number: 4303963
• Product Code: HSD
• UDI-Device Identifier: 10603295381242
• UDI-Public: 10603295381242
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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 Catalogue Number: 114020046
• Device Lot Number: HM5760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHOR PLATE SIZE 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 46; ANCHOR PLATE SIZE 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 46
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 73