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

Model Number	130742209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12532003
• Report Number: 1818910-2021-21116
• Device Sequence Number: 3431743
• Product Code: HSD
• UDI-Device Identifier: 10603295027553
• UDI-Public: 10603295027553
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 130742209
• Device Catalogue Number: 130742209
• Device Lot Number: 5357163
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR