MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI

Catalog Number UNK HIP ACETABULAR POLY

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

The surgery via tha or bha or the joint conservative surgery was performed for onfh with crushing.Great surgical results were reported, but long-term survival and postoperative complication are concerned.The object of this study was to report a case which both sides disassembly of bipolar heads (p/n: unknown) occurred within a decade of a primary surgery via bha for onfh.The patient was (b)(6) years, male, a carpenter.When he was (b)(6) years, he underwent the primary surgery via bha for his both sides hip joint for onfh.After the primary surgery, he had a pain for his right hip joint on job.By x-ray, the disassembly of the right bipolar head inside of the joint (exterior and interior of the bone head) was confirmed.The first revision surgery was performed via tha for his right hip joint.5 years after, he had a pain for his left hip joint.By x-ray, the disassembly of the left bipolar head which was similar to right hip joint was confirmed.The second revision surgery was performed via tha for his left hip joint.When both revision surgery, on both sides of hip joint, the surgeon found that the polyethylene bearings were wear and peeling notably and failure of the locking mechanism between 22mm inner head with skirt and polyethylene insert.And, degeneration of both hip acetabuli was confirmed.The disassembly of the bipolar head was caused by failure of self-centering mechanism due to degeneration of acetabuli, impingement between outer head and neck, and the patient¿s high activity.From the above, patient¿s age, activity and work were important element to consider in determining type of artificial joint.It was a report from this clinical study, not customer complaint.

• Brand Name: UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Type of Device: HIP ACETABULAR POLY/METAL HEMI
• 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: 10061631
• MDR Text Key: 191138602
• Report Number: 1818910-2020-12163
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR POLY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2020
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR POLY/METAL HEMI; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR