MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 9/10 COCR HEAD 28MM +6; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	152190060
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.B3: date of event is an unknown date.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent the primary surgery via tha with the liner in question.On an unknown date, it was confirmed the liner in question was worn out.Therefore, revision surgery will be scheduled on (b)(6) 2023.Only the liner will be replaced, but the cup and stem will also be replaced depending on the status of the other implants.If only the liner and head are replaced, use jj product implants; if the replacement extends to the cup and stem, use products made by another company (zb).It is unknown whether the implants other than reported products used in the primary surgery are jj products or not.No further information is available.New information was received from sales rep on dec 21,2023 as follows: the primary surgery was performed on (b)(6) 2002, at another hospital.There was wear of the polyethylene over time, but the final reason for the revision surgery was head-neck junction failure since the metal head was de-rotated from the aml plus stem.This is all that is known about the current situation before revision surgery is performed.New information received from the sales rep on dec 28, 2023 as follows: revision surgery was performed on (b)(6) 2023 at (b)(6) hospital and all implants were removed.After removal of the stem and liner, the screw and cup were removed after checking the fixation of the cup and to ensure compatibility.The revision procedure was then completed with a zb cementless cup and an oss (orthopedic salvage system) stem.A simple check of the stem and head after removal showed that the fixation function of the neck junction had failed.This was probably due to metal wear of the neck junction.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Although the cup was not defective, after removal of the stem and liner, the screw and cup were removed after checking the fixation of the cup and to ensure compatibility.

• Brand Name: 9/10 COCR HEAD 28MM +6
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18415475
• Report Number: 1818910-2023-26125
• Device Sequence Number: 2761085
• Product Code: JDI
• UDI-Device Identifier: 10603295276654
• UDI-Public: 10603295276654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2023
• 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): 12/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2006
• Device Catalogue Number: 152190060
• Device Lot Number: XYW-90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 01/10/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/03/2024; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2001
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDURON 10D 56 OR 68ODX28ID.; UNKNOWN HIP FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown