MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 48; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number 1136-42-026

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, 1818910-2021-05553, 1818910-2021-05554, 1818910-2021-05555.(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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 48
• Type of Device: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11528220
• MDR Text Key: 241083783
• Report Number: 1818910-2021-05556
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295006992
• UDI-Public: 10603295006992
• Combination Product (y/n): N
• PMA/PMN Number: K052472
• 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: 1136-42-026
• Device Catalogue Number: 113642026
• Device Lot Number: HP9969
• 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