MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Cardiac Arrest (1762); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Injury (2348); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.We received an asr litigation claim alleging pain, elevated blood cobalt and chromium levels, hematoma with signs of colliquation, fever, infection, inguinal abscess, swelling, pseudotumor, heart attack, walking difficulty, metallosis, injury and disability.Doi: (b)(6) 2007; dor: not indicated; left hip.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per the initial reporting; no additional investigative information will be provided.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time it was released for distribution.  the devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Brand name, common device name, lot #, part #, udi #, 510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.Initial reporter occupation: non-healthcare professional: "attorney".

Event Description

Asr litigation records received.Litigation alleges pain, elevated blood cobalt and chromium levels, hematoma with signs of colliquation, fever, infection, inguinal abscess, swelling, pseudotumor, heart attack, walking difficulty, metallosis, injury and disability.Doi: (b)(6) 2007; dor: not indicated; (left hip).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8405196
• MDR Text Key: 138284764
• Report Number: 1818910-2019-86827
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Other