MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND STAND PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738206

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 08/20/2021

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

Revision of poly from 38+6 to 38+6 retentive.Patient had reverse shoulder replacement in 2006, had a fall and fractured scapular spine, scapula was then plated and had multiple surgeries to correct shoulder, lead to uneven wear of poly and instability.Doi: 2006.Dor: (b)(6) 2021, unknown side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available photographs were reviewed, and uneven wear of polyethylene cup can be confirmed.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 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.

Event Description

Additional information received indicated that there was no surgical delay and no previous revision involving removal of depuy products.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: DXTEND STAND PE CUP D38 +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: 12459268
• MDR Text Key: 270992320
• Report Number: 1818910-2021-19879
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027379
• UDI-Public: 10603295027379
• 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,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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
• Device Lot Number: 5218905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND STAND PE CUP D38 +6MM; DXTEND STAND PE CUP D38 +6MM
• Patient Outcome(s): Required Intervention