MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 12/14/2021

Event Type  Injury  

Event Description

A patient called requesting additional information regarding a second revision she had involving depuy synthes implants.She stated that "the second one was much worse with metallosis, footdrop, numbness and tingling.The second revision on december which is much worse, a result probably long lasting for the rest of my life the injury from the failure of your device." doi: (b)(6) 2019.Dor: (b)(6) 2021.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).(b)(6) 2021 revision notes indicate the patient received a right total hip revision due to metallosis and broken liner.Upon entering the joint, black fluid was encountered along with black tissue, clear signs of metal debris noted by the surgeon.The liner was noted to be worn, fractured, and disassociated in part from the cup.Head and liner revised to dual mobility construct.No noted complications.(b)(4).(b)(6) 2021 post-op provider notes indicate the patient presented with significant 10/10 pain post revision, cramping in the right leg.Provider indicates it is likely swelling/irritation of sciatic nerve or muscles in hip/thigh resulting in foot weakness.Post-up protocols and iv pain meds given.Provider states the patient began to improve by post-op day 2.(needs new pc).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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 15561403
• MDR Text Key: 301344612
• Report Number: 1818910-2022-19767
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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 Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/26/2022
• 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 LINER POLY; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Sex: Female