MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720103

Device Problem Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

(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 and loosening of the stem at the bone to implant interface.The stem/body was replaced with new components.There were no deficiencies noted with the implants.The implants are unavailable for return.Doi: unknown, dor: (b)(6) 2021, unknown affected side.

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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND MOD EPI 1 ECC RIGHT HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg; cork 69801 ; EI 69801
• MDR Report Key: 11737618
• MDR Text Key: 247705940
• Report Number: 1818910-2021-09029
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027300
• UDI-Public: 10603295027300
• Combination Product (y/n): N
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 130720103
• Device Catalogue Number: 130720103
• Device Lot Number: 9590233
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND MODULAR HUM STEM D14 HA; DXTEND STAND PE CUP D38 +6MM; DXTEND MODULAR HUM STEM D14 HA; DXTEND STAND PE CUP D38 +6MM
• Patient Outcome(s): Required Intervention