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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Thrombosis (2100); Injury (2348)

Event Date 12/18/2007

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.

Event Description

The literature article entitled, "the anatomically difficult primary total hip replacement" written by l.C.Biant, w.J.M.Bruce, j.B.Assini, p.M.Walker, and w.R.Walsh published by the journal of bone and joint surgery accepted by publisher 18 december 2007 was reviewed.The article's purpose was to "present the results of the s-rom prosthesis used in a primary thr in patients with a significant anatomical abnormality which made the operation difficult." data was compiled from 55 hips (48 patients - average age of 52.6 years) who received the implants between july 1990 and july 2001.The article reports upon generalized results and provides patient identifiers with their identified adverse events for 6 patients in narrative description which are captured individually in linked complaints.Depuy products utilized: srom stems, srom heads, srom cups (article does not state srom cups but it is reasonable to conclude that srom cups were utilized as the stem and head were srom platforms), reamer instrument, various surface bearings including mop, mom, zop (zirconium on poly), aop (alumina on poly), coc.This complaint captures the generalized adverse events: stress shielding, proximal femoral shaft split (treated with cerclage wire), breach of femoral shaft during reaming (requiring longer srom stem), dvt, pe, superficial wound infection (treated with oral antibiotic therapy).The article does not provide adequate information to determine accurate quantities of impacted products as a patient may experience more than one adverse event.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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 HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9307742
• MDR Text Key: 166519714
• Report Number: 1818910-2019-112715
• Device Sequence Number: 1
• Product Code: KWY
• 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: 10/17/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention