MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Catalog Number 130760000

Device Problem Disconnection (1171)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 06/22/2018

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 patient came to the surgeon's clinic with pain.According to the surgeon that patient said his shoulder had not felt right for a long time.Pre-op x-ray revealed the glenosphere had disassociated from the metaglene.During surgery the suspicions were confirmed and the glenosphere had disassociated as well as the screw of the glenosphere fractured.Surgeon stated that the metaglene's placement was superior and posterior in position which accounted for scapular notching and inferior glenoid erosion.Surgeon's opinion was that the glenosphere wasn't fully seated during the primary/index operation.As a result, micromotion and time caused the implant to fatigue.New components were placed in proper position on the glenoid and confirmed seated under x-ray.It was also reported in the der that there was loosening at the unknown component at bone to implant interface.Doi: may 12, 2015; dor: jun 22, 2018; right shoulder.

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.

Manufacturer Narrative

(b)(4).Investigation summary : no device associated with this report was received for examination.Review of a provided x-ray image confirmed the reported device disassociation.Review of the device history records did not reveal any manufacturing deviations or anomalies.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380 ; 6103142063
• MDR Report Key: 7694908
• MDR Text Key: 114199494
• Report Number: 1818910-2018-64601
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760000
• Device Lot Number: 5242753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR