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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 01/01/2016

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.(b)(4).

Event Description

Operative notes were received and indicated that patient previously underwent a first left hip revision on an unknown date in 2016.During this time, the metal femoral head and poly acetabular liner were revised to a ceramic femoral head and new poly acetabular liner due to metallosis.The operative note from (b)(6) 2020 was reviewed.Within the note, the surgeon indicated the patient previously underwent a first left hip revision on an unknown date in 2016.During the first revision, the metal femoral head and poly acetabular liner were revised to a ceramic femoral head and new poly acetabular liner.The first revision was due to metallosis.There is no additional information regarding the first revision nor first revision operative notes available at the time of review.On (b)(6) 2020, the patient underwent a second left hip revision due to pain, instability, stiffness, arthrofibrosis, metallosis, inflammation, edema, difficulty walking, limb asymmetry, and a loose and migrated femoral stem.The surgeon also noted placing a constrained liner due to multiple dislocations following the first revision.There is no evidence of prior treatment for the dislocations.The cup was retained during the revision.Doi: (b)(6) 2008, dor: 2016 head and liner only, affected side: left hip.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: 10808819
• MDR Text Key: 215289286
• Report Number: 1818910-2020-24165
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 10/20/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/09/2020
• 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 FEMORAL HEAD
• Patient Outcome(s): Required Intervention