MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD; HIP ACETABULAR LINERS

Catalog Number 121887350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Osteolysis (2377); Ambulation Difficulties (2544); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/07/2019

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

The patient was revised to address pain.Doi: (b)(6) 2009, dor: (b)(6) 2019, right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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 device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.H10 additional narrative: added: b5, d10, g2, h6 (clinical code), h7, h9.H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased and anxiety.Corrected: d1, d2a, d3, d4, d6a, e1, e2, e3, g1, h6 (impact code).E3 initial reporter occupation: lawyer.

Event Description

Litigation reported that the revised product was a depuy asr hip system.Litigation also alleges that the patient has experienced severe pain, weakness, difficulty walking.Fluid retention, anxiety, fear, mental anguish, emotional damages, and elevated blood level of chromium and cobalt.Doi: (b)(6) 2009; dor: (b)(6) 2019; right 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.H10 additional narrative: added: a2 (age, dob), a4, a6, b5, b7, d4, d6a, d6b, h4, h5, h6 (clinical, impact, and medical device problem codes).H6 clinical code: - fatigue (e2312) is used to capture weakness and fatigue.- unspecified tissue injury (e2015) is 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: a1, d1, d2a, d3, d10.

Event Description

Pfs alleges pain in femur, weak, fatigue, walking difficulty, stiff bone, limited adl, excessive toxic levels of metal ions in the blood, metallosis in the right hip and tissue.After review of the medical records the patient was revised to address metallosis post mom tha, pain, elevated metal ions, fluid collection on mri.Operative note reported some blood tinged fluid, metallosis, osteolysis, minimal bone loss.Operative notes (b)(6) 2019 indicate the patient received a revision of the right total hip due to increasing metal ion levels, pain, and mri result of fluid collection.Upon entering the joint, slight osteolysis, metallosis and trunnionosis was noted, the joint was debrided.Head, liner, and cup revised.Procedure was completed without indication of complication by the surgeon.Doi: (b)(6) 2009.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 device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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: PINNACLE MTL INS NEUT36IDX50OD
• Type of Device: HIP ACETABULAR LINERS
• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8941426
• MDR Text Key: 155937782
• Report Number: 1818910-2019-102436
• Device Sequence Number: 1
• Product Code: LZO
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 121887350
• Device Lot Number: 2845690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 02/23/2021; 09/06/2022; 10/03/2022
• Supplement Dates FDA Received: 09/04/2019; 02/24/2021; 09/27/2022; 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: 6IN AML SM STATURE 12.0MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 50MM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White