MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Hematoma (1884); Pneumonia (2011); Joint Dislocation (2374); No Code Available (3191)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿limited benefits of the direct anterior approach in primary hip arthroplasty: a prospective single centre cohort study¿ by jetse jelsma, et al, published by journal of orthopaedics (2017), vol.14, pp.53-58, was reviewed.The authors performed this study to objectify that the use of the direct anterior approach (daa) results in a faster rehabilitation after thr compared to the non-daa (posterolateral and anterolateral) approach.A total of 119 patients were included for analysis.Of these patients, 87 were operated with the daa and 32 with a non-daa.Implanted components: in the daa group, a cementless tha using the corail stem, pinnacle cup, a polyethylene or ceramic liner, and femoral heads of unknown material.The non-daa group was implanted with competitor products.Results: the results will reflect those of the daa group implanted with depuy corail/pinnacle tha.The daa group displayed marked improvement in hip functionality and strength in 6-18 months follow-up.2 cases superficial infections treated with antibiotics 2 cases deep infection.1 treated with surgical debridement, antibiotics, and prostheses retention.1 treated with surgical debridement, revision of the head and liner, and antibiotics.2 hematomas.1 treated with surgical excision and 1 treated with medication 1 patient with postoperative pneumonia, dislocation, and superficial infection listed above.Treatment unknown 1 unspecified periprosthetic fracture.The location of the fracture and stage during the perioperative process the fracture was sustained is unknown.Therefore, both the cup and stem will be coded for fracture per regulatory reporting guidance.1 cerebrovascular accident- treatment unknown 1 pulmonary embolism- treatment unknown.Captured in this complaint: pinnacle cup and liner, unknown femoral head, and corail stem.This complaint contains one revision of a head and liner to treat infection and 2 surgical interventions- 1 evacuation of hematoma and 1 debridement for infection.".

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: 9322942
• MDR Text Key: 182634327
• Report Number: 1818910-2019-113522
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• 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