MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER IMPLANT; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1100-10-100

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  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

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

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 thejoint injury corrected: g1 and h6 (patient).Replaced surgical intervention with device revision or replacement.

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.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN SHOULDER IMPLANT
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8699576
• MDR Text Key: 148011626
• Report Number: 1818910-2019-95978
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (y/n): N
• PMA/PMN Number: K101996
• 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,Followup
• Report Date: 05/22/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-10-100
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Device Lot Number: 7938275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• 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
• Patient Outcome(s): Required Intervention