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 Foreign Body Reaction (1868); Unspecified Musculoskeletal problem (4535)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

70-year-old female patient received a left hip revision to treat impingement secondary to dislocation and liner disassociation.Upon entering the joint, the surgeon identified and debrided metallosis caused by metal debris.The liner was disassociated due to locking mechanism failure, causing the summit femoral stem to impinge on the failed locking ring generating wear on the trunnion and metal debris.The cup and stem were well-fixed and retained.The patient a bimentum dual mobility articulating surface to replace the revised head and liner.The procedure was completed without complications.Head, liner and stem were revised.Doi: (b)(6) 2008(cup, stem).Doi: (b)(6) 2017(head, liner).Dor: (b)(6) 2021.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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 15232294
• MDR Text Key: 297952835
• Report Number: 1818910-2022-15876
• 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: 08/16/2022

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: C4VFG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2008
• 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: ARTICULEZE M 28MM 1.5; PINN LNR CON +4 NEUT 28IDX50OD; PINNACLE 100 ACET CUP 50MM; SUMMIT POR TAPER SZ6 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female