MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Distress (2329); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle medical records complaint received ad 31 jan 2022.After review of medical records patient was revised was due to pain.Upon opening the capsule, immediately encountered a yellow appearing spongy soft tissue almost consistent with cornbread circumferentially around the acetabulum and femoral head and neck, metal debris at the base of the head at the level of the trunnion, osteolysis and pseudotumor like tissue.Cobalt and chromium is within the normal level.Doi: (b)(6) 2009; dor: (b)(6) 2021 left hip.

Manufacturer Narrative

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

Event Description

Pinnacle medical records complaint received ad 31 jan 2022.After review of medical records patient was revised was due to pain.Upon opening the capsule, immediately encountered a yellow appearing spongy soft tissue almost consistent with cornbread circumferentially around the acetabulum and femoral head and neck, metal debris at the base of the head at the level of the trunnion, osteolysis and pseudotumor like tissue.Cobalt and chromium is within the normal level.Doi: (b)(6) 2009; dor: (b)(6) 2021 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.

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: added: h6 clinical symptoms code: unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10 and h6 (removed clinical code blood heavy metal increased due to new info provided that metal ions is below 7ppb).

Event Description

Pinnacle mom litigation record received.Litigation alleges elevated metal ions poisoning, pseudotumor, permanent tissue destruction, muscle destruction, bone, and metal wear resulting to injury, pain and emotional distress.

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: metal related pathology (e1618) is being utilized to capture blood heavy metal increased and metal poisoning.Unspecified tissue injury (e2015) is being utilized to capture soft tissue injury and bone injury.

Manufacturer Narrative

Product complaint #
=
> pc-(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: added: a2 (age), b5 and h6 (clinical codes) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D6a.

Event Description

After a review of the medical records, the patient was revised to address pseudotumor, groin buttock, lateral hip pain, osteolysis, elevated metal ions, fluid collection, and consistent with metallosis.Operative note reported scarred pseudocapsule.There was an exposed fixation surface from osteolysis of the femoral calcar.Small leg length increase and offset increase.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13506147
• MDR Text Key: 285405687
• Report Number: 1818910-2022-02673
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/10/2022

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 Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 02/22/2022; 09/14/2022; 09/21/2022; 03/01/2023
• Supplement Dates FDA Received: 02/23/2022; 09/20/2022; 09/27/2022; 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HIGH OFFSET UNCEMENTED STEM; SIZE +5 36; SIZE 36; SIZE 54MM; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL STEM SUMMIT
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male