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); Nerve Damage (1979); Pain (1994); Pneumonia (2011); Joint Dislocation (2374); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

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

"article entitled ¿comparison of tri-lock bone preservation stem and the conventional standard corail stem in primary total hip arthroplasty"" written by jiang guo, jie tan, lei peng, qian song, hao-ran kong, peng wang, and hui-yong shen published by orthopaedic surgery accepted on january 16, 2021 was reviewed.The article's purpose was to compare the clinical and radiographic outcomes in between the tri-lock bone preservation stem (84 patients with 104 hips) and the conventional standard corail stem (84 patients with 115 hips) in primary total hip arthroplasties that were performed between march 2012 to may 2014.The results determined the tri-lock has similar clinical performances compared to the corail stem with some advantages in lower incidence of thigh pain, stress shielding and intra-operative fracture.Complications: trilock stem 1 intraoperative femur fracture treated with cerclage wire.1 dislocation treated with revision.2 patients with postoperative limp- treatment unspecified.3 reports of postoperative pneumonia- treatment unspecified.Corail stem: 4 patient reported postoperative pain- treatment unspecified.1 report of sciatic nerve numbness- treatment unspecified.8 intraoperative femur fractures- unspecified number treated with cerclage wires.3 reports of superficial infection- treatment unspecified.2 reports of postoperative dvt- treatment unspecified.1 postoperative periprosthetic fracture treated with revision.1 periprosthetic joint infection treated with revision.Radiographic results: the authors note there were no instances of subsidence in either group, however: trilock: 8 stems in varus and 2 in valgus, 84 stems with varying degrees of stress shielding, and 4 with ectopic ossification.Corail: 10 stems in varus and 3 in valgus, 84 stems with varying degrees of stress shielding, and 3 with ectopic ossification.".

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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 12366321
• MDR Text Key: 268093632
• Report Number: 1818910-2021-18641
• 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: 08/07/2021

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: 08/07/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention