MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720101

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/15/2020

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

The patient was revised to address humeral fracture due to fall and loosening of the humeral stem at the bone to implant interface.The patient had a delta extend reverse shoulder implanted years ago.The humeral components were revised and the metaglene, screws and glenosphere were left implanted.An 8mm unite revision stem, size 1 centered epi, 2 spacers and a 42mm + 3 poly were implanted.Doi: (b)(6) 2017, dor: (b)(6) 2020, left shoulder.

Event Description

1.It was indicated in the der that the loosening interface is bone to cement, however, the products involved (stem and epiphysis) are porocoat/cementless products.Please verify and provide the correct loosening interface.Answer: the sales rep responded over the phone, the surgeon did not like the fixation of the humeral stem and therefore elected to cement the stem in place to achieve additional fixation.The cement manufacturer is still unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed h10 additional narrative: added: b5.

• Brand Name: DXTEND MOD CENT EPI 1 HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11118102
• MDR Text Key: 225121293
• Report Number: 1818910-2021-00266
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027287
• UDI-Public: 10603295027287
• Combination Product (y/n): N
• PMA/PMN Number: K192448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130720101
• Device Catalogue Number: 130720101
• Device Lot Number: 5274705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE ECC D42MM.; DXTEND MOD CENT EPI 1 HA.; DXTEND SCREW LOCK D4.5X24MM.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND STAND PE CUP D42 +3MM.; GLOBAL UNITE STD STEM SZ 8.; METAGLENE LONG PEG +10MM.; DXTEND GLENOSPHERE ECC D42MM; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +3MM; GLOBAL UNITE STD STEM SZ 8; METAGLENE LONG PEG +10MM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR