MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-048

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/29/2020

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 doctor said the patient hip was unstable due to poor cup positioning.He replaced the cup with a competitor implant.The stem was retained and a new ceramic head was used.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020.Affected side: 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.

• Brand Name: PINN SECTOR W/GRIPTION 48MM
• 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: 10258248
• MDR Text Key: 198347750
• Report Number: 1818910-2020-15532
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010289
• UDI-Public: 10603295010289
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-048
• Device Catalogue Number: 121732048
• Device Lot Number: 9248149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; UNKNOWN HIP FEMORAL STEM; ALTRX +4 10D 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention