MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738206

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 05/04/2020

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

It was reported that the patient had her shoulder replaced.The surgeon did not know who did the surgery or when it was done.The patient was referred to surgeon because her total reverse shoulder dislocated.The x-rays indicated that this patient had a delta extend prosthesis and was dislocated inferior.The surgeon revised the implants.The existing +9 spacer, 38mm eccentric glenosphere, and 38mm + 6 poly was explanted and replaced with a 42mm + 6 eccentric glenosphere and a 42mm + 6 retentitive numeral cup was implanted.The surgeon felt this provided a stable shoulder joint.The cemented humeral stem, the metaglene base plate, and base plate screws were left implanted.There was damage to the implants and the lot # information was not obtained because they were not legible.Doi: unknown.Dor: (b)(6) 2020.Right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.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.

• Brand Name: DXTEND STAND PE CUP D38 +6MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10067207
• MDR Text Key: 191320764
• Report Number: 1818910-2020-12218
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027379
• UDI-Public: 10603295027379
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738206
• Device Catalogue Number: 130738206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE ECC D38MM; DXTEND HUMERAL SPACER +9MM; UNKNOWN SHOULDER HUMERAL STEMS; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; DXTEND GLENOSPHERE ECC D38MM; DXTEND HUMERAL SPACER +9MM; UNKNOWN SHOULDER HUMERAL STEMS; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 50