MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number 130760000

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Joint Laxity (4526)

Event Date 08/10/2022

Event Type  Injury  

Event Description

Patient with rheumatoid arthritis presented with anterior dislocation of reverse shoulder replacement which required revision to hemi arthroplasty with a cta head, this was done by removing the glenoid implants and the poly cup and converting with a 52 x 26 cta head.Index procedure was at (b)(6) hospital also on (b)(6) 2019.I was unable to obtain details of the implants which remained insitu.Also couldn¿t obtain serial numbers for the screws.Reason for revision was described as instability, however he hasn¿t ruled out infection as well, awaiting results of specimens which were obtained intra op.Doi: (b)(6) 2019; dor: (b)(6) 2022; unknown shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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 there was no delay reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence provided was reviewed and found insufficient information to identify any device issue.There was no allegation against the device.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 130760000/lot 5329055 combination.Based on the inability to find any nc¿s against the provided product code 130760000/lot code 5329055 combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• 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: 15300238
• MDR Text Key: 298663800
• Report Number: 1818910-2022-16735
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130760000
• Device Catalogue Number: 130760000
• Device Lot Number: 5329055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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
• Treatment: DXTEND GLENOSPHERE STD D38MM; DXTEND METAGLENE; DXTEND STAND PE CUP D38 +3MM; UNK SHOULDER NON-LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG