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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/02/2012

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

Literature article received entitled "the twenty-year survivorship of two cdh stems with different design features".Literature article entitled, ¿the twenty-year survivorship of two cdh stems with different design features¿ by george digas, et al, published by european journal of orthopaedic surgery and traumatology (2013), vol.23.Pp.901-906 was reviewed for mdr reportability.The authors report on the effect on long-term survival of two cemented cdh type femoral components, differing in material and design features.The authors retrospectively examined the clinical records and radiographs of 50 patients (67 hips) with low and high dislocations treated with tha in our institution, between january 1987 and december 1994.For the reconstruction of the femur, the stainless steel charnley cdh stem (depuy), with polished surface, monoblock and collarless, was used in 32 hips; the harris cdh stem (zimmer), made of cocr, precoated at the proximal part, modular and with collar was used in 35 hips.All patients were female.All acetabular components were polyethylene manufactured by smith and nephew.At the time of the latest follow-up, 11 charnley and 6 harris cdh stems had been revised for aseptic loosening at an average of 14 years (range 6¿20) and 13 years (range 2¿19), respectively.The survival rate at 20 years, with failure for aseptic loosening as the end point, was 63 % for the charnley and 78 % for the harris cdh stems.These results provide a basis for evaluation of newer techniques and designs.In the charnley group, 11 stems (34 %) in 10 patients had been revised because of aseptic loosening at an average of 14 years (range 6¿20) from the index operation.Five of the revised hips had low and 6 high dislocations.In 8 hips, both components were revised, but only the stem in the rest three.The dislocations will not be reported because the components were manufactured by smith and nephew.The score for pain improved from a preoperative mean of 3 points (range 2¿4) to a mean of 5 points (range 4¿6) at the time of the final follow-up.Similarly, the score for function improved from a mean of 2.7 points (range 2¿4) to a mean of 4.4 points (range 2¿6) and the score for range of motion from a mean of 3 points (range 1¿5) to a mean of 4.2 points (range 2¿5).Three of the 18 surviving stems were thought potentially loose at the last radiographic evaluation.There were several cemented stems in both groups.The cement used was manufactured by howmedica out of (b)(4).The authors do not specifically mention case studies or patients within the text of this study.

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).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.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9088600
• MDR Text Key: 163603826
• Report Number: 1818910-2019-105511
• 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: 09/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention