MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DLT TS CER HD 12/14 40MM +5.0; HIP FEMORAL HEAD

Catalog Number 136540720

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Cancer (3262)

Event Date 11/17/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address instability.Update 12/18/15 & 12/22/15 medical records received.The medical records and claim were reviewed for mdr reportability.The claim reported the patient with severe pain, inflammation, tissue and bone loss, metallosis, increased metal ions, abductor necrosis, dislocation and revision surgeries on (b)(6) 2014 and (b)(6) 2015.The claim reported instability and previous abductor necrosis as revision reason.There was no revision surgical report within the medical records for (b)(6) 2014.There is no new information that would change the existing investigation.The complaint was updated on: jan 8, 2015 update oct 5, 2017: litigation record received.Plaintiff was found to have necrotic bursal tissue, but no infection.Plaintiff was diagnosed with bladder cancer, which the doctors informed him was likely caused by elevated chromium and cobalt levels in his system.Complaint was updated on oct 23, 2017.

Manufacturer Narrative

(b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Pfs alleges squishing noise and difficulty in going up and down the stairs.After medical records for the mdr reportability, clinical notes reported that due to abductor necrosis which was extensive, patient had a postoperative instability and another revision was performed on (b)(6) 2014.

Manufacturer Narrative

(b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.H10 additional 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, post market surveillance, 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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DLT TS CER HD 12/14 40MM +5.0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7002168
• MDR Text Key: 91052227
• Report Number: 1818910-2017-28071
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033707
• UDI-Public: 10603295033707
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136540720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 65