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

Catalog Number UNK HIP FEMORAL STEM SROM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2017

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

Literature article entitled, ¿clinical performance of ultra-short anatomic cementless versus fourth-generation cemented femoral stems for hip replacement in octogenarians¿, published by slack incorporated, was reviewed.The aim of this study was to determine how ultra-short anatomic cementless versus cemented femoral stems affect the survival of primary total hip arthroplasties in octogenarians.Specifically, the authors investigated whether ultra-short anatomic cementless and cemented femoral components would have similar (1) functional results, (2) radiographic results, (3) revision and survival rates, and (4) complication rates in octogenarians.The authors evaluated 93 consecutive octogenarians (98 hips) in the ultra-short stem group and 78 consecutive octogenarians (92 hips) in the cemented stem group the average follow-up was 8.1 years in the ultra-short anatomic cementless stem group and 7.8 years in the cemented stem group.Ultra-short anatomic cementless and cemented stems obtained rigid fixation in octogenarians.However, the incidence of undisplaced periprosthetic calcar fracture intraoperatively was significantly higher (p=.003) in the cemented stem group.There were 43 patients lost to follow-up before 2 years postoperatively and 33 patients died in the interm of the study.No allegations of device or procedure related to deaths.Uncemented duraloc 100 or 1200 serious cup was used with 28mm biolox forte ceramic liner was used in the ultra-short stem group.On the basis of the findings of this study, the authors suggest that ultra-short uncemented stems can be used in octogenarians to reduce periprosthetic calcar fracture and make revision for infection easier.Uncemented duraloc 100 or 1200 series acetabular cup, 28mm biolox forte ceramic head was used in the ultra-short stem group.93 patients received an ultra-short anatomic uncemented proxima stem with 28mm biolox forte ceramic modular head.78 patients received an elite plus cemented femoral stem with 22mm zirconia ceramic modular head.A 22mm conventional polyethylene liner was used in the cement group, ceramic on ceramic was used too.(22mm was used because 28mm ceramic head was not available at the time of the operation).Complications: non-cemented: proxima stem, duraloc cup, 28mm biolox forte ceramic modular head, 22 biolox forte ceramic liner, duroloc cup 48 to 58mm.1 proxima stem was revised for periprosthetic fracture.2 proxima stem patient¿s were revised for infection.1 duroloc acetabular component was revised for infection.2 dislocations in proxima stem patients treated with closed reduction.1 proxima patient had nondisplaced fracture of the calcar region intraoperatively during impaction of the component.1 proxima patient had displaced postoperative fracture and was revised.Complications: cemented: charnley elite-plus stem (ortron 90), 22mm zirconia ceramic modular head, duraloc cup, 22 mm conventional polyethylene liner.17 elite patients had nondisplaced periprosthetic calcar fractures intraoperatively and were treated with 1 or cables.It was noted that the reason for the higher incidence of periprosthetic calcar fracture in the cemented group appeared to be the pressurization of the cement to obtain thigh fit in the soft bone.1 elite femoral stem was revised for aseptic loosening, no interface provided and 2 were revised for infection.2 dislocation in elite femoral stem patients, treated with closed reduction.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Images within the journal article have been reviewed.Nothing indicative of a product problem is identified.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SROM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11187149
• MDR Text Key: 231339070
• Report Number: 1818910-2021-01370
• Device Sequence Number: 1
• Product Code: MRA
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• 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 SROM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR