MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; HIP ACETABULAR CUP

Catalog Number 121722052

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Swelling (2356); No Code Available (3191)

Event Date 11/10/2014

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

Patient was revised to address a pseudotumor.Update rec'd 1/18/2016: litigation received.Litigation alleges friction and wear causing an increased in metal ion levels, pain, discomfort, and inflammation.The stem is now being added to the complaint for the alleged high metal ions.Update 4/20/16-pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain and suffering, decreased range of motion, decreased mobility, increased risk for dislocation/revision surgery/long-term health issues, walks with limp, loss of flexibility, and difficult to sit or stand for long periods of time.Medical records reported possible slight vertical acetabular cup per radiograph and mri reportedly showed a cystic lesion.Lab results reported metal ions to be less than 7 parts per billion.Revision surgical note reported metal stained fluid, abductor damage, large fluid collection and the acetabular cup was revised for being vertical.Cup is being added to complaint.

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 investigation will be reopened.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Ppf alleges metallosis.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.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 SECTOR II CUP 52MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5652451
• MDR Text Key: 45112111
• Report Number: 1818910-2016-19261
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK000306
• 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: 04/20/2016

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: 11/28/2016
• Device Catalogue Number: 121722052
• Device Lot Number: A66GS1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided; 03/27/2019; 11/27/2019
• Supplement Dates FDA Received: 06/17/2016; 04/09/2019; 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 58