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

Catalog Number	114010048
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision of a global icon due to pain.All depuy synthes products were removed.When the components were removed it looked like the patient may have had an infection.Tissue samples were taken.Primary surgery was done on (b)(6) 2018.Competitor products were then implanted.Was surgery delayed due to the reported event? no.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Other information: left side.Is the patient part of a clinical study: unknown.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
Event or Problem Description
Additional information received indicated that the patient did not have an infection.The reason for revision was loosening.
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.Added: b1 (product problem), b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ANCHOR PLATE SIZE 48
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11003886
• Report Number: 1818910-2020-26878
• Device Sequence Number: 3486642
• Product Code: KWS
• UDI-Device Identifier: 10603295381129
• UDI-Public: 10603295381129
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

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: 114010048
• Device Lot Number: 8730289
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 02/09/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/18/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK ANCHOR PG GLENOID 44; HUMERAL HEAD SIZE 48 +3
• Outcome Attributed to Adverse Event: Required Intervention