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

Catalog Number 114020050

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

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 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: crosslink anchor pg glenoid 48 product code: 113642026 lot number: h02537 dhr review 1) quantity manufactured: (b)(4) 2) date of manufacture: 9/29/2017 3) any anomalies or deviations identified in dhr: no 4) expiry date: 8/31/2027 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 : dhr review 1) quantity manufactured: (b)(4) 2) date of manufacture: 9/29/2017 3) any anomalies or deviations identified in dhr: no 4) expiry date: 8/31/2027 5) ifu reference: 090200874.

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.

• Brand Name: HUMERAL HEAD SIZE 50
• Type of Device: SHOULDER HUMERAL HEADS
• 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: 18118258
• MDR Text Key: 327904008
• Report Number: 1818910-2023-23017
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10603295381266
• UDI-Public: 10603295381266
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 114020050
• Device Lot Number: HH1013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 11/27/2023
• Supplement Dates FDA Received: 11/24/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• 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: ANCHOR PLATE SIZE 48; CROSSLINK ANCHOR PG GLENOID 48
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG