MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTEND MODECC 145EPI POR SZ1 RT; SHOULDER HUMERAL STEM ACCESSORY

Model Number	1307-20-113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Revision of a delta xtend due to dislocation and instability.The primary surgery was done about 8 weeks ago.During a physio rehab session the patient dislocated.The surgeon was able to reduce the should once the patient was asleep but we still proceeded with the plan to revise.Only the 42+3 hmo cup 1307-42-003 and 145 epiphysis 1307-20113 were explanted so the construct could be converted to a 155 epi and 42+6 retentive cup.The surgeon stated that the reason for revision was not due to any implant failure, rather the choice of implants that were used.Surgeon stated he should have done a 155 in the first place with a standard or retentive cup.The patient was also quite a big build, so the weight of his arm might have given him a false sense of stability.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available photo evidence were reviewed and does not shows an implant fracture, disassociation or any indicative related to a device nonconformance.Based on the information provided as evidence, a defect or malfunction cannot be established, therefore the allegation is not confirmed.Depuy synthes considers the investigation closed at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: XTEND MODECC 145EPI POR SZ1 RT
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14949443
• Report Number: 1818910-2022-12551
• Device Sequence Number: 17334303
• Product Code: HSD
• UDI-Device Identifier: 10603295510246
• UDI-Public: 10603295510246
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/07/2022

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: 1307-20-113
• Device Catalogue Number: 130720113
• Device Lot Number: 9600674
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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: DXTEND HIGHMO PE CUP D42 +3MM; UNK SHOULDER GLENOSPHERE DELTA XTEND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male