MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC-2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-04-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Cyst(s) (1800); Fever (1858); Foreign Body Reaction (1868); Pain (1994); Neuralgia (4413); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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 the patient has a history of right total hip, summit stem, 40 -2 head and 40 metal on metal liner with 60 pinnacle sector cup.Only the summit stem was retained.Cup, liner, head, bone screw were explanted.A biomet cup was put in with biomet liner.40 +8.5 ceramic ts head was placed on summit stem.Explanation for revision was not provided to the representative.It was not noted at the time of surgery that there was a deficient product.It was noted by the surgeon it is a metal on metal liner.Doi: unknown - dor: (b)(6) 2021 (right hip).
Additional 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) will not be performed since mom systems are obsolete.
Event or Problem Description
Medical records received.On (b)(6) 2021.The patient was revised due to failed total hip secondary to pain and metallosis.Surgical reported patient had right hip pain and a vertical acetabular component of 65 inclination angle.
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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.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).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.Review of the x-ray evidence found nothing indicative of a device nonconformance or a relation between the product and the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
Event or Problem Description
After a review of the medical records and clinical findings on (b)(6) 2018, the patient complained of right leg cellulitis and reported pain similar to periprosthetic neuralgia.And on (b)(6) 2021 the patient complained of cellulitis of the right leg, fever, and bacterial skin infection of the leg.On (b)(6) 2021 mri findings a small joint effusion is present.There is a small baker cyst and extensive bone infarcts in the distal femur and proximal tibia.Subchondral cystlike areas in the distal anterior central femur are consistent with chronic repetitive trauma.On (b)(6) 2021 mri reported 2 large complicated bursal fluid collections with one located in the region on the left iliopsoas almost 14 cm in its cranio caudad extent and the other located in the left peritrochanteric subgluteus maximus region measuring slightly greater than 13 com deep to the left iliotibial band.
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).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.

• Brand Name: 12/14 ARTICUL 40MM M SPEC-2
• Common Device Name: 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): 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: 14734520
• Report Number: 1818910-2022-11171
• Device Sequence Number: 16713435
• Product Code: LPH
• UDI-Device Identifier: 10603295032946
• UDI-Public: 10603295032946
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/17/2022
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2012
• Device Model Number: 1365-04-000
• Device Catalogue Number: 136504000
• Device Lot Number: 2454306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/20/2022; 03/01/2023; 03/28/2023; 04/28/2023; 08/21/2023; 11/21/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/20/2022; 03/20/2023; 04/05/2023; 04/30/2023; 09/12/2023; 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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: APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; SUMMIT POR TAPER SZ7 STD OFF; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White