MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-052

Device Problem Malposition of Device (2616)

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

Event Date 12/09/2019

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

After review of medical records, patient was revised to addressed painful right hip arthroplasty with pseudotumor and metallosis.Patient states that her pain was on the lateral side of the hip that it made her difficult to walk, she also had a limp.Operative note reported the trunnion demonstrated minimal metallosis.Femoral component was found to be well fixed with minimal bone loss.After head was removed trunnion had minimal wear and the stem was 10 degrees anteversion.Acetabular cup was 40 abduction and 20 degrees of anteversion.Cobalt and chromium levels are below 7 ppb.Doi: (b)(6) 2009 - dor: (b)(6) 2019 (right hip).

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Event Description

Upon review of investigator, the cup was not mispositioned and will not be reported.

• Brand Name: PINN SECTOR W/GRIPTION 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: 10236019
• MDR Text Key: 197927065
• Report Number: 1818910-2020-15044
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010302
• UDI-Public: 10603295010302
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 1217-32-052
• Device Catalogue Number: 121732052
• Device Lot Number: C3SG71000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; CORAIL2 STD SIZE 11; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 102