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

Model Number 1218-87-354

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Tinnitus (2103); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2019

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.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.

Event Description

Pinnacle litigation records received.Litigation alleges corrosion and friction wear cause from toxic cobalt-chromium metal debris resulting to elevated metal ions, pain and distress.Doi: (b)(6) 2006; dor: (b)(6) 2019; 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.

Event Description

After review of the medical records the patient was revised to address elevated metal ions.Operative note reported scarred fascia and a small amount of clear appearing synovial fluid.There was a small amount of dark staining on the trunnion consistent with mild corrosion and scar tissue.Clinical visit reported elevated metal ions 7.3, some tinnitus, vision loss, occasional tightness in his chest, groin pain, pseudotumor and aseptic lymphocyte predominant vasculitis associated lesion.

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: h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the vasculitis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: METAL ACETABULAR LINER
• 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 IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11737150
• MDR Text Key: 248283822
• Report Number: 1818910-2021-08990
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

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: 03/31/2011
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2132333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 07/27/2022; 09/27/2022
• Supplement Dates FDA Received: 08/11/2022; 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2006
• 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: PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20; UNK HIP ACETABULAR LINER METAL ULTAMET; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 84 KG