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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinic notes and radiology reports dated (b)(6) 2016.Patient presents with persistent pain, trochanteric bursitis, heterotopic ossification, and walking difficulty following right hip revision surgery.Serial radiographic studies identify a well-fixed, well-aligned right tha with minimal gluteal extraskeletal ossification.The patient received three pain relief injections to treat the pain on (b)(6) 2016.The surgeon notes that the patient was referred for a re-evaluation of his medication for depression.The injections and medication adjustment were successful.Theses events will be captured in a new, linked pc, as they are previously unreported.Doi: (b)(6) 2014 (for stem and cup); (b)(6) 2015 (for head, liner and titanium sleeve).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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 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.E3 initial reporter occupation: lawyer.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the radiology disc found that the attached x-rays do not represent the current complaint condition.Therefore the investigation could not draw any conclusions about the reported event.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 records evaluation (mre) was not performed as no lot number was provided for this device.

• 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: 10567003
• MDR Text Key: 207961932
• Report Number: 1818910-2020-20628
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/10/2020

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 FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 04/27/2021; 07/14/2021; 08/30/2022; 04/13/2023
• Supplement Dates FDA Received: 10/28/2020; 05/14/2021; 07/15/2021; 09/05/2022; 04/19/2023
• 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: CORAIL AMT COLLAR SIZE 13; PINN SECTOR W/GRIPTION 60MM; UNKNOWN HIP ACETABULAR LINERS (POLY LINER); CORAIL AMT COLLAR SIZE 13; PINN SECTOR W/GRIPTION 60MM; UNKNOWN HIP ACETABULAR LINERS (POLY LINER)
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 109 KG