MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Limb Fracture (4518); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation record received.Patient alleges pain and suffering, serious bodily injuries, and economic loss.Doi: (b)(6) 2007.Dor: (b)(6) 2019; (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Pinnacle pfs alleges displaced fracture of the lesser trochanter of the right femur, osteolysis, wear, trunnionnosis, bone fragments, fibrous tissue, scattered foreign materials, cyst, necrosis, hemorrhagic debris, prosthesis loosening and elevated metal ions.Medical records received.After review of the medical records the patient was revised due to osteolysis and wear right tha.Operative note reported moderate trunnionosis and wear on the femoral head and liner.There was a osteolytic cyst and large amount of blackened osteolytic tissue and lesion.Some comminuted fragments of the lesser trochanter.Clinical visit reported pain, weakness, walking difficulty, cyst, click in the hip, mri reported osteolytic lesion at the lesser trochanter of the femur, femoral calcar, pathologic avulsion fracture of the lesser trochanter with medical displacement of the trochanter, osteolysis, joint effusion, pseudotumor, metastatic disease.Lab result shows above 7 ppb.

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: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 12003939
• MDR Text Key: 256357191
• Report Number: 1818910-2021-12737
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 2360685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 06/25/2021; 09/28/2022; 11/09/2022
• Supplement Dates FDA Received: 06/22/2021; 06/28/2021; 10/07/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT DUOFIX TAP SZ6 HI OFF; UNK HIP ACETABULAR LINER METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 100 KG