MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136528310
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Anxiety (2328); Joint Dislocation (2374); Swelling/ Edema (4577)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that on (b)(6) 2025, the sales rep attended a girdlestone operation due to an infection.The details leading up to the girdlestone operation are as follows: (b)(6) 2023, the patient had a subtrochanteric fracture of the left femur and underwent initial surgery with a nail.It is unknown whether the nail was a j&j¿s product or not.On (b)(6) 2024, the patient had a second subtrochanteric fracture of the left femur.The nail breakage also occurred.An artificial head replacement and orif with the implants in question was performed.On (b)(6) 2024, dislocation was observed.(b)(6) 2025, there was redness around the wound and swelling, and exudate was confirmed from the wound, suggesting infection around the stem.On (b)(6) 2025, considering the patient's medical history and decline in adl, the girdlestone operation (which was scheduled for removal of all implants) was performed.The stem was preserved because it was stuck.The girdlestone operation was completed successfully with no surgical delay.The patient's medical history, medical history, other diseases currently being treated, etc.: alcoholic cirrhosis, anxiety disorder, insomnia, stasis dermatitis, right congenital cataract no further information is available.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.(b)(6).The photo investigation revealed nothing indicative of a device nonconformance at the delta cer head 12/14 28mm +1.5.With evidence provided, the reported implant dislocation cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, the sales rep attended a girdle stone operation due to an infection.The details leading up to the girdle stone operation are as follows: (b)(6) 2023, the patient had a subtrochanteric fracture of the left femur and underwent initial surgery with a nail.It is unknown whether the nail was a j&j¿s product or not.On (b)6) 2024, the patient had a second subtrochanteric fracture of the left femur.The nail breakage also occurred.An artificial head replacement and orif with the implants in question was performed.On (b)(6) 2024, dislocation was observed.2nd week of (b)(6) 2025, there was redness around the wound and swelling, and exudate was confirmed from the wound, suggesting infection around the stem.On (b)(6) 2025, considering the patient's medical history and decline in adl, the girdle stone operation (which was scheduled for removal of all implants) was performed.The stem was preserved because it was stuck.The girdle stone operation was completed successfully with no surgical delay.The patient's medical history, and other diseases currently being treated, etc.: alcoholic cirrhosis, anxiety disorder, insomnia, stasis dermatitis, right congenital cataract.No further information is available.

• Brand Name: DELTA CER HEAD 12/14 28MM +1.5
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22048125
• Report Number: 1818910-2025-08151
• Device Sequence Number: 21152384
• Product Code: LZO
• UDI-Device Identifier: 10603295033271
• UDI-Public: (01)10603295033271(17)280531(10)4176625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 136528310
• Device Lot Number: 4176625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG