MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1100-08-100

Device Problem Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The stem was uncemented.It was a post fracture.The product was replaced with a long 8mm stem, epi 1 cent and 38 +9 pe cup.The surgeon was very happy with the revised outcome.Stem had to be removed and replaced due to loosening.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE STD STEM SZ 8
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 16688763
• MDR Text Key: 312765987
• Report Number: 1818910-2023-07472
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004042
• UDI-Public: 10603295004042
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 1100-08-100
• Device Catalogue Number: 110008100
• Device Lot Number: 8088220008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DXTEND STAND PE CUP D38 +6MM; GLOBAL UNITE FX RSA EPI 1; GLOBAL UNITE STD STEM SZ 8
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female