MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND GLENOSPHERE ECC D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760042

Device Problems Fracture (1260); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

(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

The glenosphere screwing system had broken resulting in medialization of the implant causing pain for the patient as well as a decrease in shoulder mobility.A revision has been made for a replacement of prosthesis on (b)(6) 2022.The device was implanted on 2018.Doi: 2018, dor: (b)(6) 2022, unknown shoulder.

Event Description

Additional information was received indicated the following: 1.Affected side involved: right.2.Was there a surgical delay because of this event? if yes, what is the duration of the delay? the surgical delay was the intervention itself because it was a surgery recovery of a glenosphere not placed properly.The patient had persistent pain with difficulties for moving.It is the first incident occurred for the surgeon which has the habit to perform this surgical gesture.According to the op note, the glenosphere seemed to be mobile, the ablation was performed without any difficulty.Therefore, it was not dissociated to the metaglene implant.The screw breakage having been observed after ablation.Summary of op note for the implantation (b)(6) 2018): arthrotomy step by step allowing to expose the humeral head.Glenoid passage.Resection of the labrum.Placement of the guide spindle.Placement of the standard keel base with 2 screws locked upper and lower and 2 screws unlocked upper and lower.Humeral preparation until the epiphysis size 2 centered, landmark 0 with a trial of polyethylene hmo+3 - diameter 42.Placement of the definitive implants, rod diameter 14 with epiphysis size 2 centered, landmark 0, 30° of retroversion associated with a polyethylene hmo+3mm diameter and xtend depuy 42mm.Correct stability of the assembly.Reinsertion of the subcapsular on an anchor rotator cuff 2.Summary of op note for the surgical recovery (b)(6) 2022): arthrotomy allowing to notice immediately the important metallose with outflow of serous fluid.Synovectomy, exposition of the humeral epiphysis and the glenosphere.The glenosphere is mobile.The ablation was performed without any difficulty with a highlighting of a lock-up screw rupture.The base has presented a good performance but with the screw breakage, this base has to be removed in order to allow the placement of a new glenosphere (the remained screw cannot be removed).Ablation of the 4 screws, the base was removed after a passage of osteotome allowing its total release without bone damage.The plot hole was grafted with packed shavings of allograft.Ablation at the osteotome from the beak to the neck of the inferior scapula, ablation at the osteotome of the humeral metaphyseal exostosis.It was decided to place the base in a lower position, as the patient's glene allowing that.Placement of the guide spin, placement of a standard keel base with 2 screws locked upper and lower (36mm) and 2 screws unlocked upper and lower (24mm).Placement of the definitive standard glenosphere of 42mm lateralized +2mm associated to a polyethylene hmo+6mm depuy delata extend.Test was satisfying, no jump, no amplitude cam effect observed.

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 :the device associated with this report was not received for examination.Based in the attached photographic evidence, allegation was confirmed.The connection shaft is fractured.Based on the provided evidence and lack of a progressive implant imaging record, it cannot be determined that implants suffered any unintended movement from it original implantation position.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 manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

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

Massive rupture of the right shoulder rotator cuff: indication for xtend depuy reverse total shoulder arthroplasty.This patient had already benefited from a partial closure of the rotator cuff and persisted with a pseudo-paralytic shoulder.After collegial discussion, a total reverse shoulder arthroplasty was proposed to the patient.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was not received for examination.Based in the attached photographic evidence, allegation was confirmed.The connection shaft is fractured.Based on the provided evidence and lack of a progressive implant imaging record, it cannot be determined that implants suffered any unintended movement from it original implantation position.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 manufacturing record evaluation (nc search) was performed for the finished device 130760042, lot 5302057, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> visual examination of the returned device found the glenosphere screw broken, confirming the reported allegation.Based on the provided evidence and lack of a progressive implant imaging record, it cannot be determined that implants suffered any unintended movement from it original implantation position.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 manufacturing record evaluation was performed for the finished device 130760042, lot 5302057, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DXTEND GLENOSPHERE ECC D42MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LRD. 8010379; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13392580
• MDR Text Key: 284690717
• Report Number: 1818910-2022-01918
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027751
• UDI-Public: 10603295027751
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120174
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760042
• Device Catalogue Number: 130760042
• Device Lot Number: 5302057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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: DXTEND HIGHMO PE CUP D42 +6MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D14 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X30MM
• Patient Outcome(s): Required Intervention