MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND MBLOC HUM EPI 1 D8 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130708100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.
Additional 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 or Problem 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.
Additional 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 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 : 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 1 D8 STD
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14031982
• Report Number: 1818910-2022-06284
• Device Sequence Number: 4559004
• Product Code: HSD
• UDI-Device Identifier: 10603295027102
• UDI-Public: 10603295027102
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130708100
• Device Catalogue Number: 130708100
• Device Lot Number: 5300787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 05/04/2022; 06/15/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/19/2022; 05/07/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4 SCREWS; CEMENT MFG AND PRODUCT NAME UNKNOWN; DXTEND GLENOSPHERE STD D42MM; DXTEND HUMERAL SPACER +9MM; DXTEND METAGLENE; DXTEND STAND PE CUP D42 +6MM; UNK SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female