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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

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.(b)(4).

Event Description

The article entitled, "influence of the type of hip-component fixation and age of patients on mid-term revision rate of total hip replacement" written by v.Kubinec published by acta chir orthop traumatol cech.85, 2018 was reviewed.The article's purpose was to compare different brands and different brand platforms of stems and cups to compare survival rate with specific focus on analyzing the impact of implant type and component fixation technique (cemented vs.Uncemented) correlated with patient age.It is noted that multiple depuy products are listed among non-depuy products.The article reports that all implants within the study required revision for loosening for either or both the femoral stem or acetabular cup.The cement manufacturer is not identified for the cemented implants.The article provides no information regarding reported patient experience.The article does not discuss bearing surfaces of if screws were utilized and focuses on loose cups and loose stems for survivorship.Figure 1 and 2 provide photographic illustration of the different femoral stems (cemented vs non cemented).Figure 3 provides radiographic imaging for a (b)(6) year old female patient with cemented charnley stem that loosed 3 years post implantation followed by a periprosthetic fracture.The other radiographic figures portray non-depuy products as described in figure narrative description.Depuy products: ultima cemented stem, charnley monoblock/modular cemented stem, mecroblock mr uncemented stem, aml uncemented stem, ultima threaded cups (uncemented), duraloc cup (uncemented), ultima uhmwpe cup (cemented all poly) elite plus cups (cemented all poly).Adverse events: loose stems (treated by revision).Loose cups (treated by revision).Figure 3 cemented loose charnley stem for (b)(6) year old female (treated by revision).

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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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.

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.H6 patient code: no code available (3191) was used to capture insufficient information.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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.

• 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
• MDR Report Key: 10001660
• MDR Text Key: 190058345
• Report Number: 1818910-2020-11349
• Device Sequence Number: 1
• Product Code: KXA
• 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,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention