MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 48X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number 1100-48-610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Events reported in 1818910-2021-04888, 1818910-2021-05554, 1818910-2021-05555, 1818910-2021-05556.(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

This case is logged to capture the revision mentioned in (b)(4).The base of the handle of the stem inserter became loose, allowing it to slide down the shaft of the inserter, after the surgeon hammered it (in the correct location) in an attempt to remove a stem.This occurred during a revision case where a global ap was being removed.The surgeon was able to use other instruments within our shoulder extraction trays to successfully remove the stem and complete the operation successfully.The revision was due to the patient experiencing stiffness due to arthrofibrosis with a small degree of cuff damage.The cause of the revision did not have anything to do with the implants themselves.Right 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE HEAD 48X18 ECC
• Type of Device: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11528218
• MDR Text Key: 241014489
• Report Number: 1818910-2021-05553
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004615
• UDI-Public: 10603295004615
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-48-610
• Device Catalogue Number: 110048610
• Device Lot Number: HF9553
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP PC STEM 12 MM; GLOBAL UNITE HEAD 48X18 ECC; CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP PC STEM 12 MM; GLOBAL UNITE HEAD 48X18 ECC
• Patient Outcome(s): Required Intervention