MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 40+4; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550540004
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several attempts to place glenosphere were taken.When doctor pulled it was solid pit when he would twist it was loose.Doctor tried to peripheral ream again, doctor checked the peripheral screws with checker and they did not seem to be proud.Doctor re tightened the peripheral screws and gas the same issues with the glenosphere again.They switched glenosphere inserter tips and again the same issues.Surgeon re checked his positioning and still the same issues.Doctor then put the trial glenosphere back on and had no issues with it seating approximately.He then placed a trial 40+8mm glenosphere and it seated approximately.He then asked for the 40+8mm glenosphere implant and was able to get it to properly seat.No expected patient outcomes, surgeon was happy with patients rom & x-rays.This glenosphere issue caused about a 30 minute delay.Doe: nov 28, 2023 affected side: right shoulder.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Supplier dhr and cmm report were provided.A manufacturing record evaluation was performed for the finished device product code - 550540004, lot number - 333145, and no non-conformances / manufacturing irregularities were identified.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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: supplier dhr and cmm report were provided.A manufacturing record evaluation was performed for the finished device product code - 550540004, lot number - 333145, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: GLENOSPHERE 40+4
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18300017
• Report Number: 1818910-2023-25056
• Device Sequence Number: 17932133
• Product Code: PHX
• UDI-Device Identifier: 10603295547150
• UDI-Public: 10603295547150
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 550540004
• Device Lot Number: 333145
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female