MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-050

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This device was also subject of (b)(4).As the patient experienced adverse events on different days with the same device.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

68-year-old female patient received a right hip revision to treat dislocation and liner disassociation secondary to a pelvic fracture caused by a fall.Upon entering the joint, the surgeon identified and debrided metallosis caused by metal debris.The liner was disassociated due to locking mechanism failure and fractured, causing the femoral head to articulate on the cup causing metal debris.All fragments of the liner were removed, and the worn femoral head was revised.The cup and stem were well-fixed and retained.The patient received another articuleze femoral head and pinnacle constrained liner with locking ring.During hip reduction, the surgeon identified some impingement that he deemed appropriate for the patient.The procedure was completed without complications.Of note: treatment for the pelvic fracture was not included in the operative notes or medical records.Doi: (b)(6) 2008(cup).Doi: (b)(6) 2018(head ,liner).Dor: (b)(6) 2019.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This medwatch report was initially submitted on 09/22/2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket (b)(4) for additional details.

• Brand Name: PINNACLE 100 ACET 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15223768
• MDR Text Key: 297865415
• Report Number: 1818910-2022-15774
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: 10603295008545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: 1217-01-050
• Device Catalogue Number: 121701050
• Device Lot Number: CN3F91000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ENDURANCE; UNK HIP CONSTRAINED ACETABULAR LINER PINNACLE; UNK HIP FEMORAL HEAD METAL ARTICUL/EZE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female