MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Pcf and medical records received.After review of medical records, it was reported that patient was hypotensive and had acute blood lose anemia, requiring blood transfusion and had hyponatremia.Had difficulty controlling pain and anesthesia assisted with pain management plan.The patient was diagnosed with le mid and distal femoral dvt and proximal and distal politeal dvt on (b)(6).The patient was sent to operating room for irrigation and debridement of left thigh abscess, no implants were removed.Doi: (b)(6) 2016; dor: none reported; 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: ALTRX NEUT 36IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10573854
• MDR Text Key: 208139015
• Report Number: 1818910-2020-20724
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016342
• UDI-Public: 10603295016342
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1221-36-056
• Device Catalogue Number: 122136056
• Device Lot Number: C61102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ6 HI OFF; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ6 HI OFF
• Patient Outcome(s): Required Intervention