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

Model Number 130738106

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 11/27/2020

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 right delta xtend tsr.Patient underwent primary surgery in 2012 at another facility and different surgeon.Presented to current surgeon complaining of pain.Surgeon suspected cause as scapular notching.Surgery undertaken to remove poly insert, glenosphere and broken inferior metaglene screw.Broken portion of screw unable to be removed and left in-situ.Previous 38 ecc glenosphere removed and a 42 ecc inserted.Trail reduction with 42, + 6 std poly insert.Surgeon satisfied with range of motion, definitive 42, + 6 std poly impacted and shoulder reduced.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided photographs and x-ray images confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot :the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.H10 additional narrative: added: b1 (product problem) corrected: d3, g1.

• Brand Name: DXTEND RETENT 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: 11065248
• MDR Text Key: 223396936
• Report Number: 1818910-2020-27625
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027355
• UDI-Public: 10603295027355
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738106
• Device Catalogue Number: 130738106
• Device Lot Number: 2758282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOSTOP G CEM RESTR 12MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND MBLOC HUM EPI 1 D12 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW LOCK D4.5X48MM; BIOSTOP G CEM RESTR 12MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND MBLOC HUM EPI 1 D12 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW LOCK D4.5X48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR