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

Catalog Number 121701056

Device Problem Malposition of Device (2616)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: litigation alleges pain, metallosis, fluid and erosion of the acetabulum, femur and surrounding structures.Update 10/31/2016 ¿ pfs and medical records received.After review of the medical records for mdr reportability, the medical records indicated aseptic loosening of the stem, elevated cobalt levels (no labs), pain, and limping.The unknown cup is being changed to the stem.It should be noted the revision operative note hasn't been received.Part/lot is being updated.The complaint was updated on:11/22/2016.Update dec 8, 2017: medical records received.After review of medical records for the mdr reportability, in addition to what was previously reported, revision notes reported corrosion and grayish discoloration, scar tissue, pseudomembrane, and debris.Mri showed atrophy of the short external rotator muscle, without evidence of component loosening, mild patchy marrow edema along the proximal aspect.This complaint was updated on dec 12, 2017.Update 2/19/2018: the left cup was noted to be at a higher than recommended inclination.

Manufacturer 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 100 ACET CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7482430
• MDR Text Key: 107191417
• Report Number: 1818910-2018-58766
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

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 Catalogue Number: 121701056
• Device Lot Number: CN9D71000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 01/09/2019; 08/06/2019
• Supplement Dates FDA Received: 07/19/2018; 01/15/2019; 08/06/2019
• 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: 115