MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 ACET CUP 56MM; HIP ACETABULAR CUP

Catalog Number 121701056

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 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Additional 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 right hip revised in 2009 with bacterial reinfection and was revised again later in 2009 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 2009 and no report of when or why cables were placed.Date of revision will be changed to (b)(6) 2009 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.The complaint was updated on: dec 22, 2015.

Manufacturer Narrative

No device associated with this report was received for examination.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.

Event Description

Update 12/22/15- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Right hip was revised with competitor products on (b)(6) 2010.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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: PINNACLE 100 ACET CUP 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5335576
• MDR Text Key: 34686875
• Report Number: 1818910-2015-38202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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: 06/02/2011
• Device Catalogue Number: 121701056
• Device Lot Number: AW1DT1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• 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