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 Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Thrombosis (2100); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 05/03/2017

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 "midterm results of total hip replacement with subtrochanteric osteotomy, modular stem, and ceramic surface in crowe iv hip dysplasia.Literature article entitled, ¿mid-term results of total hip replacement with subtrochanteric osteotomy, modular stem, and ceramic surface in crowe iv hip dysplasia¿ by sen wang, ms, et al, published by arthroplasty today (2018) vol.4, pp.363-369 was reviewed for mdr reportability.The purposes of this study are to (1) report the mid-term results of tha with subtrochanteric transverse osteotomy using srom prosthesis and ceramic-on-ceramic (coc) surface for crowe type iv ddh; and (2) compare the wear performance between coc and metal-on-polyethylene (mop) bearing couple.The authors retrospectively analyzed 94 crowe type iv ddh patients (123 hips) treated with cementless tha in our hospital between june 2007 and december 2012.Fourteen patients (20 hips) were lost to follow-up.The s-rom (depuy, warsaw, in) prosthesis was used in all hips and subtrochanteric transverse osteotomy was performed in 74 hips.These hips were divided into 3 groups based on surface type: a group (mop, 14 hips), b group (forte coc, 58 hips), and c group (delta coc group, 31 hips).The s-rom prosthesis was used in all hips, and cone or sleeve was chosen based on proximal femur form.Thirty-five hips used cone, while 68 hips used sleeve.Three types of acetabular cup (depuy) were used: duraloc bantam cup for group a, duraloc option for group b, and pinnacle for group c, and femoral head was of metal (22 mm), forte ceramic (28 mm), and delta ceramic (28 mm), respectively.Eighty patients (103 hips) were included in the series, consisting of 8 men (11 hips) and 72 women (92 hips).Post operatively, distances, and 4 patients (5%) were able to run, swim, and do other workouts.A positive trendelenberg sign was confirmed in 16 hips (15.5%) and 5 hips (4.9%) were considered as delayed positive.There was none or slight limp in 54 patients (67.5%), moderate in 16 patients (20%), and severe in 3 patients (3.8%).Four patients were not satisfied with surgery and recovery including 3 patients who complained about knee pain during walking which resulted from valgus knee and 1 severe limp case due to short abductor lever arm.Eighty-two hips were available for radiographic evaluation and all the cups were stable but 2 cups were revised for recurrent dislocation and polyethylene wear.2 stems (2.4%) were revised for loosening (1 aseptic loosening and 1 septic loosening).Osteolysis was not detected in the coc group and was evident in 5 hips (50%) of the mop group: another hip was revised 8 years after tha resulting from severe osteolysis in gruen zone 1, zone 2 and delee zone 2.Moreover, 3 polyethylene liners showed eccentric wear.There were 8 cases of intraoperative femoral fracture,1 proximal fragment, and 7 distal fragment, all treated with cerclage wires or bands.Intraoperative femoral fracture was not detected in 2 patients (3 hips) until postoperative radiographs were obtained, therefore they had to undergo a secondary fixation surgery.Two weeks after the secondary surgery, 1 hip developed deep vein thrombosis and anticoagulation therapy was administrated.One hip developed femoral stem loosening and nonunion was diagnosed as infection, and revised 1.5 years after tha.Four hips (3.9%) had symptoms of nerve palsy: 3 of them were transient and fully recovered within 2 months, another hip partially recovered at the final follow-up with remaining numbness and sensory deficit.Six hips (5.8%) experienced dislocations: 3 hips (21.4%) in the mop group (22-mm head) and 3 hips (3.4%) in the coc group (28-mm head), including 1 recurrent dislocation treated with revision.The mean abduction angle of these cups was 46 eleven hips (10.7%) reported mild and negligible squeaking and we did not find any ceramic fracture event until the final follow-up.Overall, 4 hips underwent revision, of them 2 hips in the mop group were revised because of polyethylene wear and recurrent dislocation (fig.1).There were 2 cases of stem loosening in the coc group as described before.One was considered as aseptic loosening, the other stem showed progressive subsidence caused by small cone size.The authors do not differentiate patient harms to specific product lines.

Manufacturer Narrative

Product complaint # : (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: no.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.It should be noted that no device was returned.A complaints search was not possible as no product details were received.A review of the x-rays per (b)(4) no implant fracture or disassociation identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).Device history lot : null.Device history batch : null.Device history review : null.

• 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: 9087322
• MDR Text Key: 163415747
• Report Number: 1818910-2019-105431
• 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
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention