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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Date 09/19/2009

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 received entitled "tha with delta ceramic on ceramic".Literature article entitled, "tha with delta ceramic on ceramic: results of a multicenter investigational device exemption trial" by william g hamilton, md, et al, published in clinical orthopedic related research (19 september 2009) vol.468, pp.358-366 was reviewed for mdr reportability.This article reports the early outcomes and complications of a prospective, randomized, multicenter trial of 264 hips at eight centers, comparing 177 delta coc hip articulations with 87 delta cop hip articulations with a minimum of 2 year follow-up.The coc group was implanted with a biolox delta ceramic liner and the cop group was implanted with a marathon polyethylene liner.All patients received the same biolox delta ceramic alumina composite femoral head size 28-mm and pinnacle acetabular cup.Patients received on of five depuy cementless femoral stems: aml, prodigy, corail, summit, or s-rom.The hhs and clinical, radiological, and survivorship outcomes were similar in both groups.In the coc group, there were 4 revisions: 1 for component dislocation and 2 for femoral component loosening, and one for postoperative ceramic liner fracture and infection.There were 3 intraoperative ceramic liner fractures with one fracture that required the removal of and reinsertion of a new acetabular cup to ensure the complete removal of all ceramic liner debris.There is one patient with a ceramic liner fracture who is scheduled for a future revision surgery.The coc group had the following complications in addition to the 4 revisions: 5 intraoperative femur fractures, 2 cases of deep infection, 1 case of nerve damage, 3 additional cases of dislocation, 1 additional case of femoral component loosening, and 9 incidences of wound problems.In the cop group, there were two revision surgery due to dislocation of the acetabular articulations.The cop group had in incidence of intraoperative femur fracture, 2 cases of intraoperative chipped liners, 2 additional dislocations, and two incidences of wound problems.There were no reports of acetabular loosening of the cup or osteolysis in either group.This study did not differentiate products in relation to patient harms in greater detail than listed in the above event description.The impacted products and associated harms are listed within the text on table 4 pp.362.This study was part of a usfda investigational device exemption study (fda/ide).

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8977162
• MDR Text Key: 161590055
• Report Number: 1818910-2019-103634
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention