MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 44X15 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-44-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (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
This was a revision of a global unite anatomic total shoulder replacement, and converted to a delta xtend reverse total shoulder replacement due to rotator cuff failure and instability.The stem was well fixed and was retained, but the proximal body (110040000), head (114400600), and glenoid component (113641026) needed to be removed in order to perform the conversion procedure.I am unsure when the primary surgery was done.Unable to get the lot number for the proximal body (110040000).When the glenoid component glenoid component (113641026) was removed one of the peripheral pegs broke off which was then removed.The surgeon noted that this component was actually loose.He said this will have been caused by the instability of the shoulder exerting rocking forces on the glenoid component and eventually loosening glenoid implant.This is because the cuff was deficient.
Event or Problem Description
Additional information received stating that they cannot confirm what cement was used.Simplex is most commonly used on the glenoid.The rotator cuff failure was due to natural progression.Affected side: left side.
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.H10 additional narrative: added: b5.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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE HEAD 44X15 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10809835
• Report Number: 1818910-2020-24189
• Device Sequence Number: 4141320
• Product Code: HSD
• UDI-Device Identifier: 10603295004547
• UDI-Public: 10603295004547
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/23/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1100-44-600
• Device Catalogue Number: 110044600
• Device Lot Number: HR2129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 01/06/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/11/2021
• 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; GLBL UNITE ANT BODY 135 SZ 12
• Outcome Attributed to Adverse Event: Required Intervention