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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Fracture (1260)

Patient Problems Pulmonary Embolism (1498); Atrial Fibrillation (1729); Erosion (1750); Bone Fracture(s) (1870); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 02/01/2006

Event Type  Injury  

Manufacturer Narrative

Product complaint (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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: no.Product checked: no.Label checked: no.Product pulled from stock for inspection: no a review of complaint databases was not possible as no product details were received.It should be noted that no device was returned.The x-rays within the article were reviewed per wi 7915 no implant fracture or disassociation noted.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot: null.Device history batch: null.Device history review: null.(b)(4).

Event Description

"literature article entitled, ¿charnley cups retained during revision of the femoral component: repeated clinical and radiographic observations of 49 cups for 7-15 years¿ by peter hallmark, et al, published by acta orthopaedica scandinavica (2001), vol.72, no.5, pp.457-466, was reviewed.This article concerns 49 consecutive polyethylene cups retained in cemented first revisions of the femoral component and evaluated on several occasions 7¿15 years after the index operation.Between 1983 and 1991, 49 primary charnley cups were retained in 48 consecutive patients during revision of the femoral component.Charnley became a depuy product in 1990.This complaint does not include patients and adverse events identified as being implanted with charnley products before 1990.The authors do not specify all events by year.The total number of depuy charnley implants attributed to included adverse events is unknown.Depuy products: cemented charnley polyethylene cups, unknown femoral head, and cemented charnley femoral stem.The cement used was manufactured by a competitor.The cup revisions noted in the article were for component implanted before 1990.Results: mean inclination of the cup was 47.1 degrees on radiographic follow up- no treatment required there were noted instances of cup migration there was radiographically identified polyethylene wear greater than 2-3 mm with femoral head penetration identified on serial radiographic studies.1 postoperative dislocation treated with closed reduction 4 intraoperative femoral fractures treated with fixation 6 hips with localized trochanteric pain- treatment unspecified 2 deep infections-treatment unknown because the hips were excluded from the study 1 persistent sciatic nerve injury and dysfunction 1 pulmonary embolism 1 myocardial infarction 1 gastric ulcer 1 atrial fibrillation 2 periprosthetic acetabular fractures treated with internal fixation-no revisions.2 cases of femur penetration during intraoperative stem insertion- noted as bone injury 2 stem fractures treated with stem revision.Captured in this complaint: charnley polyethylene cup, unknown femoral head, and charnley stem.The cup and stem were cemented with competitor cement.The instances of component loosening noted in the article are not included in this complaint because there is insufficient evidence to attribute the component loosening to the devices.".

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9343547
• MDR Text Key: 185055836
• Report Number: 1818910-2019-115843
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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