MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C & MOD CATH TRL 56/28; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number 2055-56-000

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Unknown event date.The initial reporter is j&j company representative.The device associated with this report was returned for analysis.Visual examination of the product confirmed the complaint.Device presents scratches and nicks on various locations.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.A search of the complaint database found similar reports for this type of damage and the root cause was attributed to heavy use and wear out.Device was manufactured in 2016, it is over 5 years old.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in australia as follows: it was reported damaged instruments identified by cssd.No patient or surgical involvement.Surgery was not delayed.Instruments have been tagged out.No fragments were generated.It is unknown when the damage occurred.This is report 2 of 2 for (b)(4).This report is for self centering modular cathcart mod hemi hip head trial 56od x 28id.

• Brand Name: S/C & MOD CATH TRL 56/28
• Type of Device: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14803132
• MDR Text Key: 302802523
• Report Number: 1818910-2022-11763
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295084730
• UDI-Public: (01)10603295084730
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2055-56-000
• Device Catalogue Number: 205556000
• Device Lot Number: AF1045521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1