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

Model Number	1100-10-100
Medical Device Problem Codes	Fitting Problem (2183); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem 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.
Additional 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.
Additional 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.
Additional 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
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8699576
• Report Number: 1818910-2019-95978
• Device Sequence Number: 2207452
• Product Code: HSD
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/22/2019

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: 1100-10-100
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Device Lot Number: 7938275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 07/23/2021; 08/11/2021; 09/02/2021
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/19/2019; 07/27/2021; 08/12/2021; 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK ANCHOR PG GLENOID 48; GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE HEAD 48X21 ECC; GLOBAL UNITE STD STEM SZ 10
• Outcome Attributed to Adverse Event: Required Intervention