MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number 130760000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 03/23/2022

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

Revision of a delta xtend due to infection and dislocation.All components were removed and a cemented spacer was implanted.4x screws were also removed.The infection impacted the soft tissues causing the them to become lax and this resulted in a dislocation.Components were also loose as a result of the infection.Poly wear observed, which have been caused by the dislocation.

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).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: 1.Was infection confirmed? yes.2.Can you confirm the primary surgery date or the original implantation date? i¿m unsure sorry.The patient was previously operated on at (b)(6).The patients¿ notes were unavailable which i why i unable to get any further information.3.If known, please also advise the primary surgeon/hospital.The previous surgery was done in 2018 at (b)(6).4.It was indicated that there was loosening.What components were loose? on what interface did the loosening occur? all components were loose.The stem was the only cemented implant, and this was loose at the implant-cement interface.5.Was the stem retained? please verify.The stem was removed.6.Did any of the previous revisions mentioned involve depuy products? unfortunately i am unable to confirm exactly what was done previously as the patient notes weren¿t available in theatre.7.Was there a surgical delay? if yes, what is the duration of the delay? no delay reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available photographs were reviewed.Complaint is not confirmed.In order to confirm the loosening allegation, a series of x-ray images is required.Visual examination of the photographic evidence did not identify any indication it contributed to the reported event.Nothing indicative of a product problem is identified.Depuy synthese 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 : 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 METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork LS11 8DT; EI LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14031751
• MDR Text Key: 288793795
• Report Number: 1818910-2022-06287
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K062250
• 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,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760000
• Device Catalogue Number: 130760000
• Device Lot Number: 5289635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• 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
• Treatment: 4 SCREWS; CEMENT MFG AND PRODUCT NAME UNKNOWN; DXTEND GLENOSPHERE STD D42MM; DXTEND HUMERAL SPACER +9MM; DXTEND MBLOC HUM EPI 1 D8 STD; DXTEND STAND PE CUP D42 +6MM; UNK SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Sex: Female