MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 62OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Model Number	1245-80-054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Neuropathy (1983); Pain (1994); Rash (2033); Hypoesthesia (2352); Weight Changes (2607); Hyporesponsive to stimuli (2683); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
Claim letter received.Claim letter alleges impairment of sight and hearing, cardiomyopathy, hypothyroidism, polyneuropathy, skin rash, extreme weight loss, back pain and edema.About 300 ml of metal reminiscent content was extracted from the edema and analysis shows presence of a toxic level of cobalt and chrome in the patient's body.One third of the femoral head was worn out.Patient had a duraloc cup with a polyethylene insert, a competitor head and a corail cementless stem.Doi: (b)(6) 2010; dor: (b)(6) 2014; (right hip).Previous revision on (b)(4).
Additional Manufacturer Narrative
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 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).No device was received.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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: d10, g2.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 and h6 (impact code).
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.
Event or Problem Description
In addition to what was previously alleged, the patient alleges wear, metal debris, pseudotumor, soft tissue reaction: altr, armd, metallosis, and alval.

• Brand Name: DURALOC SECTOR SERIES 62OD
• Common Device Name: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopedics drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9224421
• Report Number: 1818910-2019-111355
• Device Sequence Number: 145761
• Product Code: KWA
• UDI-Device Identifier: 10603295019633
• UDI-Public: 10603295019633
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1245-80-054
• Device Catalogue Number: 124580054
• Device Lot Number: VD3BE1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 03/04/2022; 03/27/2022
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/24/2019; 03/11/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2001
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENTLESS FEMORAL STEM CORAIL; ISODUR FEMORAL HEAD NK430K/51341089; POLYETHYLENE INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male