MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER GLENOSPHERE DELTA XTEND

Catalog Number UNK SHOULDER GLENOSPHERE DELTA

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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 Description

It has been reported that a female patient age 76yrs who had a left reverse shoulder replacement (delta xtend) in 2018 has presented with a displaced glenosphere.The metaglene baseplate is still in situ but the glenosphere has tilted inferiorly leaving a 45 degree superior gap.The patient reported to him that she pushed herself up in bed with her arm and heard a crack.It appears from the xray that the glenosphere may be locked around the base of the metaglene.Doi: 2018.Dor: unknown.Affected side: left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos confirmed the reported allegation.The observed position of the glenosphere denotes an implant disassociation most likely caused by a fracture of the glenosphere central screw.It is not unreasonable to conclude that audible sound was present due to the unintended interaction between both devices during movement.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 a manufacturing records evaluation (mre) was not performed as no lot number or product code was provided for this device.

• Brand Name: UNK SHOULDER GLENOSPHERE DELTA XTEND
• Type of Device: SHOULDER GLENOSPHERE
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15200496
• MDR Text Key: 305047516
• Report Number: 1818910-2022-15563
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• 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: UNK SHOULDER GLENOSPHERE DELTA XTEND; UNKNOWN SHOULDER METAGLENE
• Patient Age: 76 YR
• Patient Sex: Female