MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ANCHOR PLATE SIZE 48; SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 114010048

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

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 07/01/2023

Event Type  Injury  

Event Description

Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for removal of osteophytes and subscapularis repair.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: on (b)(6) 2019, date of event: unk jul 2023, (right shoulder).Treatment: removal of osteophytes and subscapularis repair.

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.Device history batch null.Device history review null.

• Brand Name: ANCHOR PLATE SIZE 48
• Type of Device: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18857875
• MDR Text Key: 337181630
• Report Number: 1818910-2024-05355
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10603295381129
• UDI-Public: 10603295381129
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K212683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 114010048
• Device Lot Number: 8730289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2018
• 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 48.; HUMERAL HEAD SIZE 48.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 99 KG