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 Ossification (1428); Pulmonary Embolism (1498); Bradycardia (1751); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Inflammation (1932); Pneumonia (2011); Urinary Tract Infection (2120); Joint Dislocation (2374); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2020

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

An article/literature was received entitled "second place award: residents or hip surgeons for the treatment of displaced femoral neck fractures? a 10-year survivorship rate analysis"."literature article entitled "residents or hip surgeons for the treatment of displaced femoral neck fractures? a 10-year survivorship rate analysis" written by fernando diaz dilernia, agustin garcía mansilla, lionel llano, martín buljubasich, jose ignacio oñativia, and martin alejandro buttaro.Published by current orthopaedic practice published online/accepted by publisher july/august 2019 was reviewed.The article's purpose was to "analyze the 10-year clinical outcomes, complications, and survivorship rates of patients who had tha for displaced femoral neck fractures operated either by hip surgeons or third or fourth year orthopaedic residents." data retrospectively studied 205 displaced femoral neck fractures operated between 2004-2008.Cement manufacturer(s) were not identified.There were no patient identifiers within the article.The article included both depuy thas and non-depuy thas.The depuy thas included pinnacle and ogee all poly cups and c-stem femoral stem.Assumed depuy acetabular liners and femoral heads will be captured on complaint.Depuy products with known adverse event(s): c-stem femoral stem.Pinnacle acetabular cup.Ogee all poly acetabular cup.Unknown femoral head.Unknown acetabular liner.Adverse events: 12 cases of unknown loosening (acetabular cup and femoral stem).9 cases of dislocation treated with unspecified constrained cup and/or closed reduction.10 cases heterotopic ossification with unspecified treatment.8 cases of infection treated with irrigation and debridement, antibiotics, and retention of products.1 case of bradycardia treated with iv inotropic infusion.4 cases of pulmonary embolism treated with low molecular weight heparin.4 cases of stroke treated with thrombolysis.8 cases of pneumonia treated with antibiotics.8 cases of deep vein thrombosis treated with low molecular weight heparin.5 cases of urinary tract infection treated with antibiotics.1 case of intra-operative blood loss treated with blood transfusion.12 cases of femoral bone fracture treated both open reduction and fixation and revision.1 case of cholecystitis treated with a laparoscopy cholecystectomy.3 patients died of cardiorespiratory arrest secondary to pulmonary embolism in the early postoperative period.

Manufacturer Narrative

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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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: 12336463
• MDR Text Key: 267094804
• Report Number: 1818910-2021-18053
• 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: 07/26/2021

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: 07/26/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention