MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-730

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/14/2022

Event Type  malfunction  

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

It was reported that the inner packing damaged.It was reported that during the surgery, opened the out-box, noted the inner packing was damaged.There were no adverse consequences to the patient.No additional information could be provided.

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: visual analysis of the returned sample was performed on 136532730/ dlt ts cer hd 12/14 32mm +9.A review of the returned complaint sample was completed.Review of the sample identified that the sterile package was visible edged-deformed.The tyvek lid was separated from the sterile blister due to deformation of the edge.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.Device history lot: product code 13652730 work order (b)(4) was manufactured on 20-july-2021.A total of (b)(4) parts were manufactured to specification.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review: a manufacturing record evaluation was performed for the finished device [136532730/9830769] number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: DLT TS CER HD 12/14 32MM +9
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13723908
• MDR Text Key: 287430844
• Report Number: 1818910-2022-04467
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033486
• UDI-Public: 10603295033486
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: 1365-32-730
• Device Catalogue Number: 136532730
• Device Lot Number: 9830769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1