MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MODULAR HUM STEM D12 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130712000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/20/2021
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
The patient was revised to address peri prosthetic fracture.Patient was treated one week earlier with a plate and cable which failed.Humeral component was revised to long stem, adequate reduction was achieved.No loosening reported.No delay to surgery.Doi: (b)(6) 2019, dor: (b)(6) 2021, 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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND MODULAR HUM STEM D12 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: 11777910
• Report Number: 1818910-2021-09588
• Device Sequence Number: 19692323
• Product Code: HSD
• UDI-Device Identifier: 10603295027171
• UDI-Public: 10603295027171
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 04/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 130712000
• Device Catalogue Number: 130712000
• Device Lot Number: 5345301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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 MOD EPI 1 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND STAND PE CUP D42 +9MM; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND STAND PE CUP D42 +9MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 131