MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MBLOC HUM EPI 2 D12 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130712200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Range of Motion (2032); Discomfort (2330)

Event Date 01/01/2021

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

Revision of a reverse shoulder replacement, which included the removal of a delta xtend prosthesis.The reason for revision was patient discomfort/dissatisfaction with the initial implant (not happy with rom).The cement used in the primary surgery was not a depuy product.As this was a revision procedure, there was no extension to the surgical time.Stem was removed.Product details unknown.Dor: (b)(6) 2021.Affected side: right side.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that as this was a revision procedure, there was no extension to the surgical time and the affected side involved in this event was the right side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 MBLOC HUM EPI 2 D12 STD
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12356306
• MDR Text Key: 267826877
• Report Number: 1818910-2021-18399
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027201
• UDI-Public: 10603295027201
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130712200
• Device Catalogue Number: 130712200
• Device Lot Number: 5276940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CEMENT; DXTEND MBLOC HUM EPI 2 D12 STD; UNK SHOULDER HUMERAL STEM DELTA XTEND
• Patient Outcome(s): Required Intervention