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

Catalog Number	114010048
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Clinical adverse event received for glenoid fracture.Event is not serious and is considered mild.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2018.Date of event: (b)(6) 2020.(right shoulder) treatment: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Product description: anchor plate size 48, product code: 114010048, lot number: 8614698.1) quantity manufactured: (b)(4).2) date of manufacture: 23-10-2017, 3) any anomalies or deviations identified in dhr: no, 4) expiry date: 30-09-2027, 5) ifu reference: 090200874.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 : product description: anchor plate size 48, product code: 114010048, lot number: 8614698.1) quantity manufactured: (b)(4).2) date of manufacture: 23-10-2017, 3) any anomalies or deviations identified in dhr: no, 4) expiry date: 30-09-2027, 5) ifu reference: 090200874.

• Brand Name: ANCHOR PLATE SIZE 48
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18118259
• Report Number: 1818910-2023-23016
• Device Sequence Number: 7502963
• Product Code: PKC
• UDI-Device Identifier: 10603295381129
• UDI-Public: 10603295381129
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 114010048
• Device Lot Number: 8614698
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 11/27/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/24/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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: CROSSLINK ANCHOR PG GLENOID 48; HUMERAL HEAD SIZE 50
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG