MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377)

Event Date 03/07/2018

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

Review of poster displayed at the american academy of orthopaedic surgeons meeting, held in (b)(6) march 7th-9th, states metallosis and pseudotumor as a result of titanium taper wear in large 36 mm ceramic on ceramic total hip arthroplasty.Author indicated that two patients, each having received bilateral total hips 3 and 4 years ago, using depuy cementless corail femoral stems and pinnacle cups, paired with 36 mm ceramic-on-ceramic bearings, required revision surgery due to aseptic loosening, pain, and pseudotumors.Both patients presented with onset of groin pain, particularly after activity, and reduced range of motion.Black tissues and alval histopathologies were confirmed in both revision surgeries, with no evidence of infection.Radiographically there was extensive osteolysis in the metaphyseal part of the stems and cups suggesting aseptic loosening.There were reports of increased serum chrome and cobalt, as well as serum titanium levels that were markedly increased.The article provided the following serum lab values, but did not indicate if they pertained to both patients, or were one patient's but reflective of the issue for both: chrome 28.4 nmol/l, cobalt 37.0 nmol/l, titanium 13.6 ug/l.The author indicated that evidence for the metallosis was suggestive of stem taper wear, with taper wear identified inside and at edge of the ceramic head.Data from the study suggested wear at the stem taper due to mechanical torque from the initial friction within the ceramic bearing at motion start up when the bearing runs "dry".It was unclear from the author's report if both hips (bilateral) for each patient were revised.This complaint will address the (b)(6) male patient who had initial implants four years prior.As it is currently unclear within the author's report whether both hips of this patient were revised, a single unknown hip will be addressed and reported.Author stated that stems were revised in both patients, but the cup was revised in only one patient (but not indicated which patient).Follow-up for additional information has been initiated with the author.If new information indicates both hips were revised, then the second hip will be addressed at that time.

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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7361944
• MDR Text Key: 103182863
• Report Number: 1818910-2018-55880
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: 03/22/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/16/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR