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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/22/2019

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

Literature article entitled, ¿long-term results of cementless total hip arthroplasty for patients with high hip dislocation after childhood pyogenic infection¿, published by the journal of arthroplasty, was reviewed.The purpose of this study is to analyze the 10-year outcomes of cementless, modular total hip arthroplasty (tha) in 56 adult patients who had high dislocation secondary to childhood pyogenic arthritis.The components that were studied in this article included: pinnacle acetabular cup, srom stem, srom sleeve.The study mentions multiple dome screws, ceramic-on ceramic, ceramic-on-polyethylene, and metal-on-polyethylene articulation with no mention of manufacturer.Since the cup and stem are depuy products, we will assume the liner/head/screws to be depuy for this study.Complications noted: were limb length discrepancy, pain, limited range of motion.5 cases of transient nerve palsy.2 revisions for loosening and breakage of femoral stem.(1 of those was noted to be undersized) 4 intraoperative fractures of femur, which were fixed with cerclage cable and healed completely(fig.2).1 greater trochanter fracture, which were fixed with cerclage cable and healed completely (fig.2).1 patient had infection after 23 years and had a 2 stage revision 2 patients experienced postoperative dislocation (no mention of liner/head makeup) with closed reductions.2 patient noted swelling due to additional adductor tenotomy.

Event Description

Additional comment regarding the image review.The bone fracture reported is confirmed.It is noted however that the bone fracture existed prior placement of the depuy femoral devices.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the attached x-ray images could not confirm the reported complaint.A root cause could not be determined.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 11207243
• MDR Text Key: 227952195
• Report Number: 1818910-2021-01586
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention