MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-056

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Adverse event review: the report that the patient has now been identified as deceased has been reviewed in the context of the medical records and pfs allegations provided.It was indicated that the patient was deceased, but none of the allegations provided allege or suggest that the patient's death was in any way related to the depuy products or associated procedures.Additionally, the patient's revision surgery occurred in 2013, but per her employment record, it was noted that she did not leave her employment with avon until 2019, due to her death, six years later.It is reasonable to conclude that based upon the information currently available that there is no evidence or allegation that the death of this patient is related to depuy devices or procedures.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Pfs reported that patient post 1st revision patient still complaints of pain, aches, limitations with activity, high cobalt and chromium levels continued until death.After review of medical records, it was reported that patent suffered post operative acute blood loss anemia.Doi: (b)(6) 2005 (stem,sleeve), doi: (b)(6) 2013 (cup,screws,apex,liner,head), 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.Device history lot the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• 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: 12333831
• MDR Text Key: 266979371
• Report Number: 1818910-2021-18035
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010326
• UDI-Public: 10603295010326
• Combination Product (y/n): N
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1217-32-056
• Device Catalogue Number: 121732056
• Device Lot Number: 400791
• Date Manufacturer Received: 09/03/2021
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX56OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 56MM; S-ROM*SLEEVE PRX ZT, 18F-XXL; SROM*STM ST,30+4L NK,18X13X160; ALTRX +4 NEUT 36IDX56OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 56MM; S-ROM*SLEEVE PRX ZT, 18F-XXL; SROM*STM ST,30+4L NK,18X13X160
• Patient Outcome(s): Required Intervention