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

Model Number	130720103
Medical Device Problem Codes	Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2020
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
It was reported that the epi 1 right xtend implant was not engaged with the stem.Revision was performed to remove bone and engage prosthesis.Doi: (b)(6) 2020, dor: (b)(6) 2020, right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added d7.Corrected h6(patient, device).H6 3191 no code available is used to capture patient codes device revision and replacement and joint injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.

• Brand Name: DXTEND MOD EPI 1 ECC RIGHT HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10568021
• Report Number: 1818910-2020-20677
• Device Sequence Number: 2880763
• Product Code: KWS
• UDI-Device Identifier: 10603295027300
• UDI-Public: 10603295027300
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K071379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130720103
• Device Catalogue Number: 130720103
• Device Lot Number: 5352485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 11/02/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/30/2020; 11/03/2020
• 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: UNK SHOULDER HUMERAL STEM DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR