MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-058

Device Problem Malposition of Device (2616)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address a pseudotumor.After review of medical records, it was stated that the patient was revised to address pain, pseudotumor and osteolysis.Revision notes reported erosion of proximal femur, extensive osteolysis, metallosis, very vertical acetabular component, large tissue mass psuedotumor formation, extensive osteonecrosis, and cyst on the posterior wall.Lab data shows cobalt ion level is above 7 ppb.Doi: (b)(6) 2005; dor: (b)(6) 2017; right 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.

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.

• Brand Name: PINNACLE SECTOR II CUP 58MM
• 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: 9915664
• MDR Text Key: 186581477
• Report Number: 1818910-2020-09980
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009856
• UDI-Public: 10603295009856
• 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
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-058
• Device Catalogue Number: 121722058
• Device Lot Number: Y3HCY1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +5; PINNACLE BONE SCREW 40 MM; PINNACLE MTL INS NEUT36IDX58OD; SUMMIT DUOFIX TAP SZ8 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR