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 Naturally Worn (2988)

Patient Problems Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Primary anatomic shoulder replacement on (b)(6) 2014.Last 2 years, increasing stiffness in shoulder joint, with moderate degree of discomfort.Currently unable to abduct arm past level of shoulder.Surgeon stated glenoid was a b2 glenoid at this surgery.All components well fixed, no evidence of infection and with concentric wear on glenoid poly component.All components removed (humeral episiotomy required); and a competitor rsa prosthesis (zimmer comprehensive) implanted, using augmented glenoid component.

Event Description

Additional event information received stating that the affected side was left shoulder involved.No instruments broke during surgery.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.

• 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: 10528776
• MDR Text Key: 206785920
• Report Number: 1818910-2020-19968
• 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,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1136-42-026
• Device Catalogue Number: 113642026
• Device Lot Number: 544337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP HUMERAL STEM 12MM; GLOBAL AP PC STEM 12 MM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP HUMERAL STEM 12MM; GLOBAL AP PC STEM 12 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR