MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-07-000

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from the toxic heavy metals resulting to muscle, tissue and bone injury, metallosis, metal wear, scar tissue formation, pain and limited adl.Also suffered emotional trauma and distress.Doi: (b)(6) 2009; dor: unrevised ; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H6 clinical symptoms code: metal related pathology (e1618) used to capture blood heavy metal increased and metal poisoning and unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.

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.

Event Description

Medical records received.On (b)(6) 2022, the patient was revised due to elevated metal ion levels due to the left metal-on-metal total hip replacement.Operative findings revealed consistent synovitis on metal on metal, black corrosion product at trunnion.The patient presented with elevated metal ions after staged bilateral hip replacements.The patient underwent revision of the right hip with conversion to ceramic on a highly cross-linked polyethylene bearing with persistent elevation in cobalt 5.7 and chromium 3.4 and was indicated for revision of the left hip replacement to ceramic on the poly bearing.Surgical reported that there was staining at the backside of the liner and inside the cup.

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.H10 additional narrative: 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 : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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 Description

Medical records were received and stated the following: after review of the mr the patient was revised to address elevated metal ions.Operative findings reported synovitis consistent with mom.Black corrosion product at trunnion without damage of the trunnion.Scar tissues were excised.Patient had hpi stiffness, decreased mobility and limited mobility.Pathology reported metallic particulate debris and corrosion products.Clinical visit reported there is atrophy in the external rotator muscle bellies, tendons, scarred to posterior pseudocapsule.Hip abductors are mildly tendinotic, mild hyperintensity is noted in the region of the trochanteric bursa.On (b)(6) 2016 mri impression for the left hip is mild left iliopsoas bursitis, gross osteolysis or large fluid collection surrounding the left hip prosthesis.Doi: (b)(6) 2009.Dor: (b)(6) 2022 left hip.

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: the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The reported allegation cannot be confirmed.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 Description

Medical records received.In addition to what was previously reported.After review the patient was revised to address depression and weakness, pathology report metallic particulate debris and corrosion.Imaging reported mild nonspecific synovial expansion.There is atrophy the short external rotator muscle bellies, tendons which are scarred to the posterior pseudo capsule.The hip abductors are mildly tendinotic with areas of slight fraying.Mild- hyperintensity is noted in the region of the trochanteric bursa.Slight iliopsoas tendinosis.Trace fluid is noted decompressing into the psoas bursa.The rectus femoris is mildly tendinotic proximally.Femoral head shows circular corrosion.Clinical visit on (b)(6) 2016 reported hip pain, bilateral hamstring tendinopathy with partial tearing at the insertion where there is bursitis.Mild left iliopsoas bursitis, weakness joint swelling and pain.Synovitis consistent with mom.Black corrosion at the trunnion.

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.H10 additional narrative: 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).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+8.5
• 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 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14875636
• MDR Text Key: 295066667
• Report Number: 1818910-2022-12104
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033004
• UDI-Public: 10603295033004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060031
• 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: 06/05/2023

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: 03/23/2014
• Device Model Number: 1365-07-000
• Device Catalogue Number: 136507000
• Device Lot Number: 2874737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 03/01/2023; 03/28/2023; 04/25/2023; 05/22/2023; 07/03/2023; 08/17/2023; 11/07/2023
• Supplement Dates FDA Received: 07/07/2022; 03/13/2023; 04/12/2023; 04/26/2023; 06/06/2023; 07/03/2023; 08/25/2023; 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+8.5; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN SECTOR HA ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; SUMMIT DUOFIX TAP SZ5 HI OFF; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White