MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. APEX HOLE ELIM POSITIVE STOP; HIP OTHER IMPLANT

Catalog Number 124603000

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/04/2010

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

Litigation alleges patient suffers from toxic cobalt chromium metal debris, pain, and instability.Update 12/9/15- pfs and medical records received.Pfs and medical records were reviewed for mdr reportability.Pfs reported pain, fevers, loss of mobility, loss of marital intimacy, difficulty walking and difficulty completing activities of daily living.Medical records reported bacterial infection of hip, abscess in periarticular area with staphylococcus, patient unable to walk, pain, severe allergy to cobalt and that patient had left hip revised in 2008 with bacterial reinfection and was revised again (b)(6) of 2008 and again on (b)(6) 2010 (reimplanted).It is not known what products were implanted in the 2008 revision or if antibiotic spacers were placed.The revision surgical report dated (b)(6) 2010 noted removal of antibiotic spacer, i&d of femur and acetabulum and removal of cables that were placed.There is no revision surgical reports for 2008 and no report of when or why cables were placed.Date of revision will be changed to (b)(6) 2008 since only year was reported.There were no lab result reports for infection or metal ions within medical records.Acetabular cup and hole eliminator will be added to the complaint for the infection.Part/lot updated.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combinations since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

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).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: APEX HOLE ELIM POSITIVE STOP
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5334619
• MDR Text Key: 34665188
• Report Number: 1818910-2015-38200
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2011
• Device Catalogue Number: 124603000
• Device Lot Number: AT3A21000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72