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

Model Number 1217-22-052

Device Problem Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent total hip arthroplasty on the left hip several years ago.A depuy srom stem and pinnacle cup along with an ultamet metal on metal bearing was implanted in the patient.Patient complained of pain and it was determined that a revision was needed.Patient underwent revision total hip surgery on (b)(6) 2019 at (b)(6) hospital.Upon opening of the fascia, brownish tissue was observed.A pseudo tumor was observed.Head was removed and a mild amount of black "corrosion" could be seen around the inside of the 36 mm head and on the trunnion, but not a tremendous amount to be concerned of the trunnion of the stem.Ultamet liner was removed using the pinnacle constrained poly removal tool.Cup was in good condition and a poly liner was then inserted as well as a ceramic srom head.Due to the amount of pseudo tumor and suspect looking tissue, the doctor determined it was an adverse reaction to the metal on metal articulation.Doi: unk.Dor: (b)(6) 2019; left hip.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9868367
• MDR Text Key: 188363594
• Report Number: 1818910-2020-08933
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: AX4D21000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR