MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 40; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Catalog Number	113640026
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revised tsr global icon and apg+ due to loosening of apg+ and instability.Global icon was well fixed but had an approximate 50 degrees of retroversion.This was revised to a cemented global unite stem.Apg+ was lifting off the bone both superior and inferior but had good fixation on central peg.This was revised for the same size matched apg+ implant but fully cemented.Pt had good cuff and operation was completed.
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).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: revised tsr global icon and apg+ due to loosening of apg+ and instability.Global icon was well fixed but had an approximate 50 degrees of retroversion.This was revised to a cemented global unite stem.Apg+ was lifting off the bone both superior and inferior but had good fixation on central peg.This was revised for the same size matched apg+ implant but fully cemented.Pt had good cuff and operation was completed.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed the middle prong fractured of the crosslink anchor pg glenoid 40.Additionally, device has extraction marks over their surface.Even though there is no specific cause for the fracture observed, consideration must be given to all other potential influences such as the extraction process, surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.With evidence provided, implant loosening cannot be confirmed as there is no chronological information nor specific dates to verify the event.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the crosslink anchor pg glenoid 40 would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: CROSSLINK ANCHOR PG GLENOID 40
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20084685
• Report Number: 1818910-2024-18197
• Device Sequence Number: 7811075
• Product Code: KWS
• UDI-Device Identifier: 10603295006954
• UDI-Public: (01)10603295006954(17)270930(10)M11N05
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113640026
• Device Lot Number: M11N05
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 11/14/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/11/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHOR PLATE SIZE 42.; CROSSLINK ANCHOR PG GLENOID 40.; HUMERAL HEAD SIZE 44.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female