MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379

Device Problems Corroded (1131); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 that the patient experienced severe pain and discomfort, suffering, injury, emotional distress, disability, disfigurement, partial or complete loss of mobility and loss of range of motion.

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.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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Udi: (b)(4).No code available use for medical device removal, fear, elevated metal ions.

Event Description

Ppf alleges metal wear, metallosis and elevated metal ions.Pfs alleges walking difficulty, inflammation, anxiety and fear.After review of medical records, patient was revised to addressed failed metal on metal left total arthroplasty with extensive abductor muscle necrosis.Revision notes indicated upon entering in to the joint, fluid was under tension and had evidence of metal debris.There was evidence of both abductor muscle necrosis and capsular tissue necrosis involving more than 50% of abductor muscles.There was small amount of shuck.Upon inspection of taper and bearing surface of femoral head, which had minimal evidence of corrosion.The taper of the stem was in good condition with no evidence of corrosion.Attention was on acetabular component, there was evidence of corrosion at the taper of the liner interface with pseudo membrane formation on the under surface of acetabular liner.Added demographic data of patient, medical history, surgeon, product details of liner and head in impacted products.Also added stem due to elevated metal ions.Doi: (b)(6) 2008 dor: (b)(6) 2018 left hip.Cn(wipro).

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 device manufacturing (mre) review will not be performed even when product/lot information is known.It has been determined that, for the mom platform and related allegations an mre is not required.

• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8218244
• MDR Text Key: 132112743
• Report Number: 1818910-2019-79943
• Device Sequence Number: 2
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/09/2019; 01/15/2020; 12/09/2021; 12/09/2021
• Supplement Dates FDA Received: 01/14/2019; 01/28/2020; 12/22/2021; 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG