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 Problem Muscular Rigidity (1968)

Event Date 11/01/2021

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

Patient was revised due to stiff shoulder on the left side and was revised to a reverse tsa.Patient has a prior mdr on (b)(6) 2021.Patient has a history of left tsa with loose glenoid component, explanted and revised on (b)(6) 2021.Doi: (b)(6) 2021 dor: (b)(6) 2021 left shoulder.

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.

Event Description

A.Lot number: global unite head 44x18 ecc (110044610/68660z).B.Was the event due to natural progression? c.Please confirm the quantity of depuy cmw 2 20g (3322020/9242374).Answer: lot information is not available.It is not known if its natural progression.It would have been depuy 2 & the lot # is not known.

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.H10 additional narrative: added: b5 and d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12833126
• MDR Text Key: 280933473
• Report Number: 1818910-2021-25458
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295006978
• UDI-Public: 10603295006978
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

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: J8777P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/22/2021; 12/07/2021
• Supplement Dates FDA Received: 11/25/2021; 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 44; DEPUY CMW 2 20G; DEPUY CMW 2 20G; GLOBAL UNITE HEAD 44X18 ECC
• Patient Outcome(s): Required Intervention