MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RESTORATION MODULAR BODY; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 06/12/2023

Event Type  Injury  

Event Description

Surgeon sent an x-ray, asked if we could provide removal equipment for the stem.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: unknown restoration modular distal stem; cat #unknown; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned to the manufacturer.

Event Description

Surgeon sent an x-ray, asked if we could provide removal equipment for the stem.Update: "diagnosis is periprosthetic hip fracture.Patient had gone to er after being unable to ambulate.The reason for revision was a fractured stem on x-ray.Intra-op finding was a broken trunnion of a femoral stem implant.The implants revised were a femoral stem, a femoral head, and a smith and nephew polyethylene that was articulating in the socket.There were not any allegations against other revised implants only the dictation from the previous surgeon was available as this was implanted at a different institution.The records showed that the stem was a restoration modular 23 plus 10 body and a 16 x 155 distal stem.The explanted head was a 28mm plus 12 head.Left hip: update: "the physician used [the body/stem separator instrument] with the intention of removing the body, following the recommended surgical technique.The instrument broke.The result was to remove the stem as one piece instead of 2, which resulted in doing an extended trochanteric osteotomy per the physician to remove the stem.".

Manufacturer Narrative

Reported event: an event regarding crack/fracture and periprosthetic fracture involving an unknown restoration modular body was reported.The crack/fracture event was confirmed via evaluation of the returned device.Periprosthetic fracture was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices was performed as part of the material analysis: "conical distal stem with fracture location highlighted by the arrow.On visual examination, the fracture was observed through the female taper of the cone body where the locking bolt assembles.The distal end of the cone body remained attached to the distal stem and the femoral head and insert remained attached to the proximal end of the cone body.Also included in the image are the cone body and a chuck adapter.Two fractured wing pieces of the chuck adapter were not returned for analysis.Chuck adapter stereo microscope image of the fracture surfaces associated with the chuck adapter is shown.The fracture surface shows extensive mechanical damage, therefore nothing was noted on the mode of fracture.Cone body stereo microscope imaging of the fracture surfaces associated with the distal and proximal ends of the stem are shown respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o), direction of propagation (p) and final fracture location (f) were determined.The macroscopic surface features observed on the fracture surface indicate the component fractured due to fatigue." material analysis: a material analysis was performed on the returned devices which concluded the following: "review of the restoration modular hip system confirmed fracture through the cone body and fracture of the chuck adapter.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the cone body due to fatigue.No manufacturing or material related defects were observed on the device surfaces examined.Characterisation using stereo microscopy confirmed fracture of two of the wing pieces of the chuck adapter.No manufacturing or material related defects were observed on the device surfaces examined." clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a revision left total hip arthroplasty at some point in the past using a restoration modular femoral stem.The patient developed a fracture of the femoral stem which necessitated revision.I can confirm that the revision procedure with the restoration modular implant occurred since i was able to review the x-ray.I am able to confirm the fracture of the restoration modular stem and the subsequent revision after the fracture since i was able to review those x-rays.The root cause of this event cannot be determined with certainty.The causes of femoral neck prosthetic fracture are multifactorial including surgical technique factors, implant fixation factors, patient factors including activity level and bmi, and implant factors.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination to determine if there are any defects in the implant itself.According to the summary, the restoration modular stem was a +10 body using a +12 femoral head.Given the patient's elevated bmi and this construct, it is possible that a fatigue fracture occurred." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to fracture of the neck of the restoration modular body and periprosthetic fracture of the femur.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a revision left total hip arthroplasty at some point in the past using a restoration modular femoral stem.The patient developed a fracture of the femoral stem which necessitated revision.I can confirm that the revision procedure with the restoration modular implant occurred since i was able to review the x-ray.I am able to confirm the fracture of the restoration modular stem and the subsequent revision after the fracture since i was able to review those x-rays.The root cause of this event cannot be determined with certainty.The causes of femoral neck prosthetic fracture are multifactorial including surgical technique factors, implant fixation factors, patient factors including activity level and bmi, and implant factors.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination to determine if there are any defects in the implant itself.According to the summary, the restoration modular stem was a +10 body using a +12 femoral head.Given the patient's elevated bmi and this construct, it is possible that a fatigue fracture occurred." a material analysis was performed on the returned devices which concluded the following: "review of the restoration modular hip system confirmed fracture through the cone body and fracture of the chuck adapter.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the cone body due to fatigue.No manufacturing or material related defects were observed on the device surfaces examined." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN RESTORATION MODULAR BODY
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17277459
• MDR Text Key: 318561238
• Report Number: 0002249697-2023-00751
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

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_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 127 KG