MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND STAND PE CUP D42 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130742206

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Joint Dislocation (2374)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Inveterate dislocation of the device with severe pain and functional impotence/discomfort.Device implanted on (b)(6) 2020.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.Depuy synthese 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 was provided for this device.H10 additional narrative: added: e4 corrected: e3.

• Brand Name: DXTEND STAND PE CUP D42 +6MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12254102
• MDR Text Key: 264479911
• Report Number: 1818910-2021-16645
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027546
• UDI-Public: 10603295027546
• Combination Product (y/n): N
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: 130742206
• Device Catalogue Number: 130742206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +6MM; GLOBAL UNITE FX RSA EPI 1; GLOBAL UNITE REV STEM SZ 10; UNK SHOULDER GLENOSPHERE DELTA XTEND
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR