MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-08-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	12/15/2020
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
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.
Additional 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.
Event or Problem Description
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.

• Brand Name: GLOBAL UNITE STD STEM SZ 8
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11118065
• Report Number: 1818910-2021-00262
• Device Sequence Number: 14433960
• Product Code: HSD
• UDI-Device Identifier: 10603295004042
• UDI-Public: 10603295004042
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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 Model Number: 1100-08-100
• Device Catalogue Number: 110008100
• Device Lot Number: 8338044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/02/2021
• 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 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR