MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-048

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Pain (1994); Muscle/Tendon Damage (4532)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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

Pinnacle litigation record received.Patient alleges pain, loud squeaking noise and 3 years post index procedure.During the revision tha surgery, the surgeon noted that the ceramic femoral head was found to be articulating with the superior lateral portion of the acetabular cup and complete wear at the portion of the liner was seen.Portion of the lateral rim of the acetabular liner was broken free.The liner thinned on the fractured side due to wear and creep.Doi: (b)(6) 2019 - dor: (b)(6) 2022.(left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.Photo evidence provided was reviewed and found evidence that links the cup to a disassociation event.Even though the device was not present on the evidence, the mating liner damage confirms a disassociation between the liner and the cup.Additionally, the material transfer evidence found oh the mating ceramic head evidences implant noise.The reported condition was confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation was performed for the finished device (121722048/j17y30) product and lot numbers, and no non-conformances were identified.Device history review : a manufacturing record evaluation was performed for the finished device (121722048/j17y30) product and lot numbers, and no non-conformances were identified.

• Brand Name: PINNACLE SECTOR II CUP 48MM
• 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: 16395709
• MDR Text Key: 309735415
• Report Number: 1818910-2023-03942
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009801
• UDI-Public: 10603295009801
• 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: 02/17/2023

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: 1217-22-048
• Device Catalogue Number: 121722048
• Device Lot Number: J17Y30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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: ALTRX +4 10D 32IDX48OD; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female