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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Dislocation (2374); Thrombosis/Thrombus (4440); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 05/17/2022

Event Type  Injury  

Event Description

Clinical notification received for revision due to dislocation.Date of implant: (b)(6) 2004; date of revision: (b)(6) 2022; right hip.Treatment: removal of depuy products (unspecified).Were depuy components removed: yes.

Manufacturer Narrative

Product complaint # (b)(4).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 : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Event Description

Operative notes reviewed: on (b)(6) 2022, patient's right hip was revised to address aseptic loosening of the femoral stem at the implant to bone interface, and femoral stem implant migration (subsidence and external rotation).The liner, stem and femoral head were revised, while the cup was retained.The stem and head were replaced with competitor devices.She had no surgical complications.Intraoperative cultures taken on (b)(6) 2022 came back negative for infection.On (b)(6) 2022, patient was seen in the office following two episodes of posterior hip dislocation treated both times with closed reduction.The patient was currently on antithrombotic treatment to address a deep vein thrombosis, so there was concern about performing a revision to address the dislocations at that time.While no operative records are available for (b)(6) 2022, an implant device log record from that date indicates that the patient received a competitor brand dual mobility cup, liner and femoral head (along with appropriate competitor acetabular cup fixation screws).At the conclusion of this apparent revision surgery, there are no longer any depuy products remaining.Given the events reported for revision surgery on (b)(6) 2022, the femoral head and stem present at the time of this complaint have been identified as a competitor products.Specific product information remains unknown with respect to the cup and liner present at the time of the revision, but per the clinical database notification, they appear to be depuy devices.The prior revision from (b)(6) 2022 does not appear to have been addressed in ecm.An activity has been initiated to review this medical records review for purposes of updating the current complaint, as well as addressing this newly identified revision surgery adverse event from (b)(6) 2022, and for the deep vein thrombosis event that occurred between 08 (b)(6) 2022.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14986938
• MDR Text Key: 295693626
• Report Number: 1818910-2022-12834
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/02/2022; 08/23/2022
• Supplement Dates FDA Received: 08/19/2022; 08/23/2022
• 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: UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic