MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; HIP ACETABULAR CUP

Catalog Number 121722056

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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 pain.Update 4/19/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported allergy to metal with hot flashes, pale, clammy, sweaty hands, anxiety, pain, significant fluid around hips, sleep issues, metal toxicity, rashes, fatigue, limited range of motion,chills, tinnitus and hearing loss with being homebound related to pain.Medical records reported weakness, decreased range of motion, metal reaction with fluid collections, inflammatory response, dystrophic ossification and joint effusions with metallic fragments bilaterally.Lab results for metal ions greater than 7 parts per billion.Radiographs reportedly showed osteolysis in zones 1 and 7 of left femur and a vertical acetabular cup.No revision surgery completed per report at this time.Stem added for elevated metal ions, cup added for malposition, and part/lot updated.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the liner.The liner is exempt from device history record review.No other reports found against the remaining product/lot code combinations.X-rays and medical records were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.

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.Additional narrative: 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 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5652302
• MDR Text Key: 45108859
• Report Number: 1818910-2016-19264
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2016

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: 12/09/2019
• Device Catalogue Number: 121722056
• Device Lot Number: D77LA1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided; 12/04/2019
• Supplement Dates FDA Received: 06/24/2016; 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 84