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

Catalog Number 121722052

Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804); Failure to Disconnect (2541); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Edema (1820); Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Not Applicable (3189)

Event Date 12/10/2014

Event Type  Injury  

Event Description

Patient was revised to address pain and mechanical issues, such as grinding.

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).

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 femoral head and insert.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combination.X-rays were received and reviewed.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 at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

Pfs alleges injury, soreness and clunking sensation, ringing in ears and numbness.Pff has no allegation.After review of medical records for mdr reportability, the patient was revise to address failed metal to metal total left hip arthroplasty.Revision notes reported there was some metallosis in the trochanteric bursa, has metal staining of the joint capsule, unsuccessful dislodging the liner and cup and decided to remove entire acetabular construct and with minimal bone loss.Mri of the lower extremity reported left hip arthroplasy that there is a large left greater trocanteric bursal fluid collection, edema is noted and trochateric bursitis.Clinic visits reported pain, memory loss, and redness.7/24/2014 mri musculoskeletal pelvis reported trochanteric bursitis, fatty infiltration, atrophy left quadratus femoris muscle.Mild bony cystic change in the right acetabulum and there is tearing of superior labrum.

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.Additional narrative: corrected: adverse event problem (device code).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, 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: 4384546
• MDR Text Key: 16859266
• Report Number: 1818910-2015-10186
• 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: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2011
• Device Catalogue Number: 121722052
• Device Lot Number: AA5FP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 76