MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-32-710
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported to bfarm: "recurrence of inlay dislocation after tep implantation on (b)(6) 2021.First dislocation of the inlay on (b)(6) 2022, on (b)(6) 2022 change of the inlay, on (b)(6) 2022 another inlay dislocation occurred during deep bending.Intraoperatively, no inlay could be inserted in a stabile manner in the implanted cup.".
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :the device associated with this report was received for examination.Visual examination of the returned femoral head denoted a remarkable worn appearance at the part.It was possible to identify a disassociation event among poly liner and metal cup since it was found that occurred a transfer of the titanium cup material onto the surface of the ceramic head.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner disassociation and does not signify any product error.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 : quantity manufactured: (b)(4).2) date of manufacture: 02/2019.3) any anomalies or deviations identified in dhr: no non-conformances nor deviations.4) expiry date: 01/2024.5) ifu reference: (b)(4).Device history review : a manufacturing record evaluation was performed for the finished device (136532710/9051220) product and lot numbers, and no non-conformances were identified.H10 additional narrative:  added: h4 corrected: h3.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary the device associated with this report was received for examination.Visual examination of the returned femoral head denoted a remarkable worn appearance at the part.It was possible to identify a disassociation event among poly liner and metal cup since it was found that occurred a transfer of the titanium cup material onto the surface of the ceramic head.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner and cup disassociation and does not signify any product error.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 1) quantity manufactured: (b)(4).2) date of manufacture: 02/14/2019.3) any anomalies or deviations identified in dhr: no non-conformances nor deviations.4) expiry date: 01/2024.5) ifu reference: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device (136532710/9051220) product and lot numbers, and no non-conformances were identified.

• Brand Name: DLT TS CER HD 12/14 32MM +1
• Common Device Name: 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15451033
• Report Number: 1818910-2022-18243
• Device Sequence Number: 12180862
• Product Code: HTQ
• UDI-Device Identifier: 10603295033462
• UDI-Public: 10603295033462
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1365-32-710
• Device Catalogue Number: 136532710
• Device Lot Number: 9051220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/03/2022; 10/19/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/03/2022; 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female