MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX56OD; METAL ACETABULAR LINER

Catalog Number 121887456

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation records received.Litigation alleges toxic cobalt-chromium metal ions in the body causing pain, injury to the muscle, tissues and bone.Plaintiff also suffered emotional trauma and distress.Mri reported pseudotumor due to negative reaction to metal debris.Doi: (b)(6) 2009; dor: (b)(6) 2020: right 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 complaint database search and/or manufacturing record evaluation (mre) will not be performed.

Event Description

Clinic visits reported of large extensive fluid within the greater trochanter, mild dependent synovitis, stiffness and limited range of motion.Mri reported of cystic pseudotumor.

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).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).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.Udi: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, it was reported that the patient complained of his hip popping out.It was also indicated that the patient resents with impairments/limitations in joint integrity/rom, pain, balance, muscle performance, sensory integrity, posture, motor function and aerobic capacity.The patient was then revised for failed right total hip arthroplasty due to wear of articular bearing surface of joint prosthesis, adverse metal tissue reaction with pseudotumor with pain and dysfunction refractory to non-operative measures.Operative notes reported that upon opening the fascia, there was evidence of pseudotumor throughout the periarticular soft tissues as well as the capsule.Scar and debris were removed from about the stem junction.

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 complaint database search and/or manufacturing record evaluation (mre) will not be performed.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; 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: 11691194
• MDR Text Key: 246273301
• Report Number: 1818910-2021-08241
• Device Sequence Number: 1
• Product Code: KWA
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 121887456
• Device Lot Number: 2654133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2008
• 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: 11/13 S-ROM 40MM M SPEC+12; PINNACLE 300 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 16F-LRG; SROM STM ST,36+6L NK,11X16X150; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG