MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1100-30-000

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/22/2019

Event Type  malfunction  

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

It was reported that while converting a global unite to a reverse , it was noticed that the unite proximal body was cold welded and 2 screw drivers were broken trying to get it apart.The reverse screw driver was damaged trying while inserting the locking screw.This mdr includes the implants that were removed.Doi: unknown, dor: (b)(6) 2019, unknown shoulder.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the joint injury.Replaced surgical intervention with device revision or replacement.

Manufacturer Narrative

Product complaint # : (b)(4).Followup information revealed there is a loss of rotator cuff muscles; given the current available information, it cannot be ruled out that there may potentially have been an injury to the rotator cuff during the primary implantation of total shoulder arthroplasty products.As such, understanding that there are number of possible steps within the procedure where such an injury could occur, an unknown shoulder implant will be reported to capture this event.The previously reported incident of the "unite proximal body was cold welded to the stem" was reported in error as this did not meet the definition of a malfunction.This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 10
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8699574
• MDR Text Key: 148012318
• Report Number: 1818910-2019-95979
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004356
• UDI-Public: 10603295004356
• Combination Product (y/n): N
• PMA/PMN Number: K133834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-30-000
• Device Catalogue Number: 110030000
• Device Lot Number: 8047913
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 48; GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE HEAD 48X21 ECC; GLOBAL UNITE STD STEM SZ 10