MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); No Code Available (3191)

Event Date 03/13/2013

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.(b)(4).Occupation: attorney.

Event Description

Patient was revised to address elevated cobalt/chrome levels, along with radiographic changes in her hip.Update: 4/5/13 - litigation papers received.Litigation alleges pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ions and particles to be released into the patient's bone, blood, and bone.Update ad 30 oct 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf, pfs, sticker sheets and medical records.In addition to what were previously alleged, ppf alleges loosening of cup, fracture (bone) and metallosis.Pfs alleges, range of motion, osteolysis, metallosis and fracture.After review of medical records, patient was revised to address failed right metal on metal total hip arthroplasty with osteolysis and metallosis.Revision notes reported metal debris was encountered with evidence of metallosis.It was also stated that the cup appeared to have good fixation.Added date of birth, lawyer, medical history, laboratory data, facility name, account name, patient harm, udi, expiration date of head and unknown hip implant due to alleged fracture (bone).Corrected patient identifier.Doi: (b)(6) 2004; dor: (b)(6) 2013; (right hip).Please see (b)(4) for the allegation after fist revision.

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8482830
• MDR Text Key: 140918159
• Report Number: 1818910-2019-89733
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 66