MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 28MM +5.0; HIP CERAMIC FEMORAL HEAD

Catalog Number	136528720
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.Corrected data: d6a, d6b.
Additional Manufacturer Narrative
Product complaint#: (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported patient was revised to address recurrent right total hip instability (dislocations) and chronic abductor dysfunction secondary to greater trochanter fracture non-union, with insufficient bony bed along the lateral proximal femur to attempt internal fixation of this fracture.Patient was treated with revision of the modular femoral head and acetabular liner to a constrained articulation.Cup and femur were well-fixed and retained.There were no complications.Dislocation #1 on (b)(6) 2024: patient presented to emergency department with right hip pain.Patient had knelt down to pull up her sock when she felt a sudden "pop" sensation in her right hip, experiencing pain 10 on 1-10 scale.On (b)(6) 2024: office post-op follow-up appointment: surgeon noted postoperative course was complicated by patient having developed foot drop with diminished sensation in her sciatic nerve distribution, which was concerning for sciatic nerve neuropraxia versus palsy secondary to local anesthetic infiltration near the nerve.¿ neuropraxia is a form of peripheral nerve injury caused by compression or stretch which may resolve spontaneously within weeks or months of injury.Also presented with posterior buttock pain, weakness and numbness in her right foot.Gabapentin was prescribed for the nerve pain in the foot, and she was referred to an interventional pain specialist to address the buttock pain.She continued on touchdown weightbearing to the right leg; anterolateral hip precautions for 6 weeks; and abductor precautions for 12 weeks.She was using oxycodone for pain.These complications appear to have occurred because of the hip revision surgery on (b)(6) 2024.Dislocation #2: on (b)(6) 2024, patient presented to emergency department with right hip pain.Patient had a right total hip revision 4 months prior, and then 2 months prior she had a hip dislocation requiring reduction.Currently, she was putting a brace on her lower leg to help with her right foot drop that was a complication of her prior surgery when she felt the hip slip out of joint and experienced immediate pain.Doi: on (b)(6) 2024, dor: on (b)(6) 2024, affected area: right hip.
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.H11 additional narrative: added: b6, d1, d10 (concomitant).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DLT TS CER HD 12/14 28MM +5.0
• Common Device Name: HIP CERAMIC FEMORAL HEAD
• 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24951596
• Report Number: 1818910-2026-07314
• Device Sequence Number: 10105966
• Product Code: LZO
• UDI-Device Identifier: 10603295033318
• UDI-Public: (01)10603295033318(17)290630(10)4530867
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 136528720
• Device Lot Number: 4530867
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 04/22/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PINN LNR CON +4 NEUT 28IDX50OD; UNK HIP CONSTRAINED ACETABULAR LINER PINNACLE; UNK HIP FEMORAL HEAD CERAMIC TS; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown