MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX50OD; HIP ACETABULAR INSERT/LINER

Catalog Number 122132150

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 12/09/2010

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

(b)(6) 2015 pfs and medical records received.Pfs and medical records reviewed for reportability.Pfs reported difficulty with activities of daily living, emotional distress, consequences related to metal ion exposure, pain, painful itchy rash, dislocations, hip fracture, confined to wheelchair, loss of independence and homebound.Medical records and revision surgical report noted popping, instability, several episodes of subluxation, and deficient abductors.

Manufacturer Narrative

11/20/15-pfs and medical records received.Pfs and medical records reviewed for reportability.Pfs reported difficulty with activities of daily living, emotional distress, consequences related to metal ion exposure, pain, painful itchy rash, dislocations, hip fracture, confined to wheelchair, loss of independence and homebound.Medical records and revision surgical report noted popping, instability, several episodes of subluxation, and deficient abductors.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified no other reports against the femoral head and one other against the liner.Review of the liner device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Medical records were reviewed.The investigation can draw no conclusions with the information made available.Based on the inability to determine root cause, the need for corrective action has not been indicated.

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.  h10 additional narrative:  udi: (b)(4).Added: b5, d2b, d5, and h6(patient code).Corrected: a1, and b3.H6 patient code: no code available (3191) used to capture medical device removal.

Event Description

Ppf alleges pulmonary embolism and bone fracture.

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.H10 additional narrative: added: h6.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: 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: ALTRX +4 10D 32IDX50OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5313437
• MDR Text Key: 33966802
• Report Number: 1818910-2015-37939
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2013
• Device Catalogue Number: 122132150
• Device Lot Number: CW5MC1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; 10/09/2019; 02/27/2020
• Supplement Dates FDA Received: 02/05/2016; 10/28/2019; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 104