MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-354

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/13/2019

Event Type  Injury  

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 Description

Pcf and medical records received.After review of medical records, patient was revised to address primary osteoarthritis of the right hip.Patient alleges chronic pain, stiffness, walking difficulty, swelling, difficulty in wearing shoes and socks, difficulty with stairs, painful antalgic gait, limp, arthralgias, joint swelling, and myalgias.Physical exam stated decreased strength, tenderness, bony tenderness, swelling, and crepitus.Laboratory results stated elevated metal ions.Operative notes stated of 5 cc of black fluid was aspirated from the hip joint.Scar tissue was noted.Doi: (b)(6) 2008.Dor: (b)(6) 2019; (right hip).Patient is bilateral.Please see (b)(4) for the 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.

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 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: b5, d10, h6 (clinical and medical device problem code).H6 clinical code: appropriate term / code not available (e2402) is used to capture musculoskeletal system (e16).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Litigation alleges that the corrosion and friction wear believed to have cause amounts of toxic cobalt-chromium metal debris to be release into the plaintiff tissues surrounding the implant.Plaintiff began experiencing pain and difficulty in and around his implant.Metal ions were found to be elevated.

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 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: a4, b5, b7, h6 (clinical and medical device problem codes) updated: h6 (impact code) h6 clinical codes: appropriate term/ code not available (e2402) is used to capture blood heavy metal increased and joint crepitation - musculoskeletal system (e16).Swelling/ edema (e2338) is used to capture swelling and edema.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Ppf alleges pseudotumor, metal wear, metallosis, elevated metals.After review of medical records, the patient was revised for head and liner exchange, operative notes reported black fluid was aspirated.Surgeon noted that there was no significant metallosis within the synovium.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this complaint was not received for examination.The photo investigation cannot confirm the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10056305
• MDR Text Key: 190967151
• Report Number: 1818910-2020-12094
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2485951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2007
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; CORAIL2 LAT COXA VARA SIZE 13; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 108 KG