MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2014

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.(b)(4).

Event Description

The literature article entitled, "total hip arthroplasty for hip fractures: 5-year follow-up of functional outcomes in the oldest independent old and very old patients" written by daniel godoy monzo´n, md, kenneth v.Iserson, md, mba, jose´ jauregui, md, carlos musso, md, francisco piccaluga, md, and martin buttaro, md published by geriatric orthopaedic surgery & rehabilitation 2014, vol.5(1) 3-8 doi: 10.1177/2151458514520700 in 2014 was reviewed for mdr reportability.The article reports on results from patients older than 80 years old that received depuy c-stem with ogee cup.Intraoperative complications include oxygen desaturation during cementation (2), fractures treated with cerclage (2), transfusions (37 with ranges of 1-5 units).During hospital stay complications: confusional syndromes (11), fever syndromes (3), urinary tract infections (3).Follow up complications: hip dislocation with intervention of reoperation or closed reduction (5), dvt (3), pe (1), wound infection requiring surgical intervention (1).No deaths occurred intraoperatively and 36 deaths total occurred but not related to implantation.The article does not clarify if hospital stay complications received interventions.The article does not provide adequate information to distinguish how many patients may have experienced more than 1 adverse event/complication.Therefore accurate quantities of impacted products is unknown.The article does not specify if the dvt and pe occurrences received interventions.The article only identifies the stem and cup (all poly) as depuy products.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9158070
• MDR Text Key: 166751506
• Report Number: 1818910-2019-107684
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention