MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130710000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision of reverse shoulder for suspected infection, explants sent off for culture, photo of scan attached.Surgeon removed previous rotator cuff repair anchor sitting in humeral canal as they suspect it could have been responsible for stem subsiding into varus and infection.As this was a revision procedure, there was no extension to the surgical time.
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 at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND MODULAR HUM STEM D10 HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12318319
• Report Number: 1818910-2021-17785
• Device Sequence Number: 17278508
• Product Code: PHX
• UDI-Device Identifier: 10603295027126
• UDI-Public: 10603295027126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 07/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 130710000
• Device Catalogue Number: 130710000
• Device Lot Number: 5120652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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 D38MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND STAND PE CUP D38 +3MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND STAND PE CUP D38 +3MM
• Outcome Attributed to Adverse Event: Required Intervention