MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND STAND PE CUP D42 +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130742209

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/09/2021

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

Surgery: revision of left shoulder delta xtend.Reason for revision - infection.The 42mm screw was very difficult to remove and delayed the operation by approximately one hour.Initially unlocked screw with locking screwdriver internal rod and then used locking screwdriver (without internal rod) to unscrew it.However one of the ¿prongs¿ from the top of the screw sheared off so the locking screw driver would not grip/engage properly to unscrew it.The surgeon had to drill through the screw centrally and use the trusts screw removal instruments to remove the screw and it came out in 3 or 4 parts.All implants were retained by the hospital.No adverse consequences during surgery.Primary surgery conducted on - (b)(6) 2021.

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 : 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.H6 appropriate term / code not available (e2402) is used to capture unspecified infection (e1906).

• Brand Name: DXTEND STAND PE CUP D42 +9MM
• 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: 12532003
• MDR Text Key: 273302811
• Report Number: 1818910-2021-21116
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027553
• UDI-Public: 10603295027553
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130742209
• Device Catalogue Number: 130742209
• Device Lot Number: 5357163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND STAND PE CUP D42 +9MM; DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND STAND PE CUP D42 +9MM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR