MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720101

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

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 part did not fully seat into the global unite stem.No problems with the stem and no delay to surgery.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> examination of the returned device cannot confirmed the reported event.There was no quality issue identified with the delta xtend epiphysis.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
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> delta xtend epi ha body (wo (b)(4)): ¿ product code 130720101, work order (b)(4)was manufactured on 02-jul-2021.¿ all raw materials met specification.¿ 9 parts were manufactured to specification.¿ scrap: 3 parts from this lot were scrapped: scrap code a1094: this concerns epi ctq 2 ¿ taper circlarity.There is no correlation between this scrap reason and the failure mode of the complaint.Scrap code a866: this concerns ha coating defects.There is no correlation between this scrap reason and the failure mode of the complaint.Scrap code a211: this concerns scratches.There is no correlation between this scrap reason and the failure mode of the complaint.There were no non-conformances associated with this lot.

• Brand Name: DXTEND MOD CENT EPI 1 HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12309296
• MDR Text Key: 266094188
• Report Number: 1818910-2021-17626
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027287
• UDI-Public: 10603295027287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192448
• 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,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130720101
• Device Catalogue Number: 130720101
• Device Lot Number: 9827963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DXTEND MOD CENT EPI 1 HA.; DXTEND MOD CENT EPI 1 HA