MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HUMERAL HEAD SIZE 50; SHOULDER HUMERAL HEADS

Model Number	1140-20-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 foraminotomy surgery (not for the study shoulder) event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2019, date of event: (b)(6) 2020 (right shoulder).
Additional Manufacturer Narrative
Product complaint # (b)(4).The complaint database has been updated to state that the adverse event "foraminotomy surgery (not for the study shoulder)" is no longer is possibly related to device or procedure, but has been changed to definitely not related to device or to procedure.Per clinical process, this now indicates that this adverse event no longer meets the definition of a medical device complaint.The adverse event is unrelated to device or procedure, and therefore, there is no contribution by depuy products or procedure towards the adverse event.Clinical database now indicates ae is not related to device or procedure.As a consequence, this complaint will be downgraded and moved to an npi status.
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 = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: HUMERAL HEAD SIZE 50
• Common Device Name: SHOULDER HUMERAL HEADS
• 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: 14753022
• Report Number: 1818910-2022-11310
• Device Sequence Number: 16674791
• Product Code: PKC
• UDI-Device Identifier: 10603295381266
• UDI-Public: 10603295381266
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K212683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2022

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: 1140-20-050
• Device Catalogue Number: 114020050
• Device Lot Number: HF6858
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 07/13/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/07/2022; 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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: ANCHOR PLATE SIZE 50; CROSSLINK ANCHOR PG GLENOID 48; HUMERAL HEAD SIZE 50
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG