MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problems Corroded (1131); Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Thyroid Problems (2102); Anxiety (2328); Discomfort (2330); Osteolysis (2377); Sweating (2444); No Code Available (3191)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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 was revised for unknown reasons.Update rec¿d 03/22/2017 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain, discomfort, inflammation, elevated ions.

Manufacturer Narrative

The device associated with this report was not returned.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Added: (patient, device).

Event Description

Update 14 jul 2017: medical records received.In addition to what was previously alleged, pfs alleges trouble sleeping, high anxiety, click & movement in hip area, excessive thirst, terrible sweating, metal taste in mouth, fatigue, gastrointestinal problems, and possible thyroid difficulties.After review of medical records for mdr reportability, it was reported that the patient was revised to address adverse reaction to metal.Revision notes reported turbid dishwasher-type of fluid typical for a metal-on-metal reaction, necrotic inner layer of capsule secondary to adverse reaction to metal, osteolytic debris around the femoral head and rim of the socket, socket uncoverage as the cup was a little horizontal and generously anteverted, bone loss, corrosion material at the trunnion.The cup was retained to preserve bone stock.Clinic notes report swelling of right hip, discomfort, clicking and radiology reports femoral stem lucency, small fluid around the hip, and mild to moderate muscle atrophy.Laboratory results for cobalt/chromium were above 7ng/ml.Updated product information.This complaint was updated on: 07 aug 2017.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear and metallosis.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6474932
• MDR Text Key: 72177753
• Report Number: 1818910-2017-16146
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68