MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 40; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number	1136-40-026
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Muscle/Tendon Damage (4532)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for biceps tendonitis after tenodesis.Event is not serious and is considered mild.Event is possibly related to device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): 06/08/2020, (right shoulder).Treatment: medical intervention/modification (details unspecified).
Additional 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 : dhr was reviewed.1.Quantity manufactured was (b)(4) pieces.2.Date of manufacture was 7/17/2018.3.No deviations or anomalies were observed.4.Expiry: 2023-06.5.Ifu reference 090200457 rev k.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 40
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12283053
• Report Number: 1818910-2021-17188
• Device Sequence Number: 4303964
• Product Code: KWS
• UDI-Device Identifier: 10603295006954
• UDI-Public: 10603295006954
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1136-40-026
• Device Catalogue Number: 113640026
• Device Lot Number: HZ7007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: ANCHOR PLATE SIZE 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 46
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 73