MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Swelling (2091); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/16/2019

Event Type  Injury  

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.Initial reporter occupation: lawyer.(b)(4).

Event Description

Medical record received.After review of medical record, patient was revised to address left hip hardware dislocation.Patient experienced pain, swelling, was not able to move due to pain.Patient underwent closed reduction.Doi: (b)(6) 2019 -dor: (b)(6) 2019 (left hip).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10683055
• MDR Text Key: 211447270
• Report Number: 1818910-2020-22342
• Device Sequence Number: 1
• Product Code: KWY
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 86