MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number 130760000

Device Problems Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address loosening of the metaglene/ glenosphere at the implant to bone interface.It reported that the glenosphere did not appear to be tightened locked down all the way.Bone loss around the metaglene appeared to contribute to loosening of that component.The reported implant was a non-cemented.Original implant date was unknown.No surgical delay.Doi: unknown, dor: (b)(6) 2021, right shoulder.

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 :a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12219747
• MDR Text Key: 263371136
• Report Number: 1818910-2021-15937
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

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: 130760000
• Device Catalogue Number: 130760000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D42 +6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR