MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number	130760138
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to loosening of metaglene and glenosphere.Screws were also broken.Patient also experienced pain and possible infection.There was no surgical delay.Doi- (b)(6) 2012.Dor- (b)(6) 2023.Affected side- right shoulder.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient was revised due to loosening of metaglene and glenosphere.Screws were also broken.Patient also experienced pain and possible infection.There was no surgical delay.Doi- (b)(6) 2012; dor- (b)(6) 2023; affected side- right shoulder.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "20_jul_2023_22_03_37_10593".Visual analysis of the photo revealed the bottom section of the dxtend glenosphere std d38mm covered with blood residues.The device appears to be assembled with the mating metaglene.However, no defects that could have contributed to the reported event were observed.The overall complaint was not confirmed as the observed condition of the dxtend glenosphere std d38mm would not contribute to the complained 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: DXTEND GLENOSPHERE STD D38MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17450258
• Report Number: 1818910-2023-15859
• Device Sequence Number: 7347809
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130760138
• Device Lot Number: 5126325
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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 METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X42MM; DXTEND STAND PE CUP D38 +6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG