MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE ECC D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	130760038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional 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.Investigation summary = > the device associated with this report was not received for examination, however, the x-ray images revealed implant dislocation between the cup and glenosphere.No indication of product malfunction or product error was noted.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.
Event or Problem Description
It was determined after testing that patient had an infection which would require a stage 1 removal of all depuy reverse shoulder implants.During the surgical case the surgeon was attempting to extract the humeral stem.After connecting to the stem with the impaction handle, he began to tap the top flange of the handle with the slotted mallet (ref.# (b)(4), lot # so2029058) that is included in the shoulder removal instrument set.While using the poly tipped end of the mallet to do this, the poly tip sheared off and landed on the floor.The humeral stem was then removed easily without further incident.A few minutes later, during the removal of the metaglene locking screws (3 in total), as the surgeon was removing the final screw, one of the tabs on the end of the locking screwdriver (ref.# (b)(4), lot # 5285866) broke off and also landed on the operating room floor.Since the screw was already loose and about to come free of the metaglene, the surgeon was able to pull it free.All implants were removed as planned without additional surgical time or injury to the patient.Doi: (b)(6) 2018.Dor: (b)(6) 2020.Left shoulder.

• Brand Name: DXTEND GLENOSPHERE ECC D38MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10928659
• Report Number: 1818910-2020-25836
• Device Sequence Number: 19904321
• Product Code: KWS
• UDI-Device Identifier: 10603295027744
• UDI-Public: 10603295027744
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: MM 49-12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 130760038
• Device Catalogue Number: 130760038
• Device Lot Number: 5317683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR