MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 44; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number 1136-41-026

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

Patient Problems Cyst(s) (1800); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2021

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

Revision of shoulder - 1st stage removal of all humerus and glenoid components, with intent for 2nd stage to be a conversion to a reverse shoulder replacement.The reason for revision was a bone cyst behind the glenoid component.The decision to convert to a reverse shoulder (in a second stage) was made intra-op due to the patient's poor rotator cuff quality.As this was a revision there was no extension to the surgical time.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 44
• 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: 12075312
• MDR Text Key: 258629701
• Report Number: 1818910-2021-13736
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295006978
• UDI-Public: 10603295006978
• 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: 05/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1136-41-026
• Device Catalogue Number: 113641026
• Device Lot Number: EX4L51
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP HUMERAL STEM 12MM; CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP HUMERAL STEM 12MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR