MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-352

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.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

The patient had metal on metal revision.Plastic liner and new head were implanted.No further information available.After review of the medical records the patient was revised to address failed right hip replacement with adverse metal reaction and placement of antibiotic beads.Revision note indicated that there was small murky fluid collection around the hip and some trunnion corrosion.There was no impingement noted.Laboratory findings showed elevated chromium and cobalt level.The unknown liner and head in the impacted product were updated and added the stem to capture the reported corrosion and elevated metal ions.Doi: unknown.Dor: (b)(6) 2019.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 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 : 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.

Event Description

Patient alleged that a particulate debris from pinnacle devices caused severe inflammation, severe pain, tissue and bone loss and other related diseases, and elevated metal ion.The known friction wear was believed to have caused amounts of toxic cobalt-chromium metal debris to be released into patient's tissue surrounding the implants.Mri had findings of adverse local tissue reaction.Patient alleged physical, mental, and emotional injuries.Patient experienced and will experience limited to partial or complete loss of mobility, loss of range of motion, mental anguish, and diminished enjoyment of life.Doi: (b)(6) 2006.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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.Synthese initial reporter occupation: lawyer.

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 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

Ppf alleges abductor muscle repair, metallosis, and pseudotumor.Patient complains mild discomfort.Head and liner were removed.Pfs alleges that patient experienced numbness in lower legs and feet due to metallosis, cannot lift feet when walking.

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: 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 NEUT36IDX52OD
• 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: 10465669
• MDR Text Key: 204723162
• Report Number: 1818910-2020-18982
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083642
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-352
• Device Catalogue Number: 121887352
• Device Lot Number: 1965164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2005
• 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: ARTICULEZE M HEAD 36MM +8.5.; PINNACLE MTL INS NEUT36IDX50OD.; PINNACLE SECTOR II CUP 52MM.; SUMMIT POR TAPER SZ5 STD OFF.; ARTICULEZE M HEAD 36MM +8.5; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ5 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 59 KG