MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND STAND PE CUP D38 +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738209

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 06/13/2022

Event Type  Injury  

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 Description

It was reported that the patient needed some bone spurs removed.The surgeon decided to replace the poly while the joint was open.There was no surgical delay.Doi: (b)(6) 2017.Dor: (b)(6) 2022.Affected side: unknown.

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 STAND PE CUP D38 +9MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14915321
• MDR Text Key: 295241211
• Report Number: 1818910-2022-12306
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027386
• UDI-Public: 10603295027386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 130738209
• Device Catalogue Number: 130738209
• Device Lot Number: 5286276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female