MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-050

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Unintended Movement (3026); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the cup spun out.It had little to no bone in-growth.The liner was partially disassociated.The cup was extremely vertical.It was also reported that the cup was loose at bone to implant interface.Doi: (b)(6) 2015, dor: (b)(6) 2020, affected side: 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.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• 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: 10410683
• MDR Text Key: 203100273
• Report Number: 1818910-2020-18184
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009818
• UDI-Public: 10603295009818
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-050
• Device Catalogue Number: 121722050
• Device Lot Number: 661064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX50OD; CORAIL AMT COLLAR SIZE 10; DELTA CER HEAD 12/14 32MM +1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR