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 Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Medical records received.After review of medical records, the patient was revised for right hip arthroplasty failure with instability secondary to adverse local tissue reaction and component malposition.It was indicated the patient develop altr with pseudotumor was well as anterior instability with dislocation/ subluxation and pain.Operative notes reported that there was a gross evident of altr with gray unhealthy murky-appearing fluid.The entire synovium was covered in black reactive necrotic tissue.The cup was in poor position, a bit abduction and slightly over anteverted.Doi: (b)(6) 2009.Dor: (b)(6) 2019; right hip.The patient has bilateral hip implants, please see (b)(4) for the left hip.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided x-ray image was able to confirm the allegation of cup mispositioning.The root cause could not be determined.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 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: 10427776
• MDR Text Key: 203627894
• Report Number: 1818910-2020-18424
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: DY7ER1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ2 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR