MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 28MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	17-2800E
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "patient allegedly felt some squeaking and mild grinding of her hip implant.She claims that her hip gave out while stepping out of the shower.Patient was being revised for possible fractured ceramic head.".
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text: not returned to the manufacturer.
Event or Problem Description
It was reported that "patient allegedly felt some squeaking and mild grinding of her hip implant.She claims that her hip gave out while stepping out of the shower.Patient was being revised for possible fractured ceramic head.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "image shows the returned pieces of the alumina ceramic head and the trident alumina insert / sleeve assembly.On visual examination, fracture of the head was observed with three large pieces, eighteen small pieces and several fragments returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion.[.] stereo microscope imaging was performed on the three large pieces of the head, as shown.Due to an intentional bias in the taper dimensions, the contact pattern characteristic of normal head/neck assembly is a continuous ring of stem metal transfer located near the proximal end of the tapered surface [1].The three large pieces were examined for evidence of this metal transfer ring, with arrows highlighting the ring.Figures show the presence of crack arrest lines which are indications of overload fracture." material analysis: a material analysis was performed on the returned device which concluded the following: "review of alumina ceramic head, catalogue # 17-2800e, lot code 47115702 confirmed fracture.Characterisation using stereo microscopy confirmed the head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined." -clinician review: a review of the provided medical records by a clinical consultant indicated: "undated/unlabeled: x-ray ap hip.Secure fit style stem with some midportion bony ingrowth, but there is a pedestal.There are hypertrophic changes in the proximal femur.There is a trident style acetabular shell, uncemented, with a single screw that looks stable.There bearing looks consistent with an alumina metal-backed shell.The femoral head is fractured and subsided onto the stem.Conclusion/assessment: no medical records from the index procedure, or radiographs were provided for review.No pre or postop management of the revision procedure were provided for review.From the data provided a patient sustained a fracture of a ceramic femoral head.It appears to be in an alumina on alumina bearing with a metal-backed alumina acetabular liner.Event confirmation: fracture of a ceramic head can be confirmed.A revision procedure can be confirmed only by the explanted implants.Root cause: the root cause of the revision would be a fractured ceramic head.The root cause of the ceramic head cannot be determined." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the ceramic head.Material analysis of the returned device indicated the following: "on visual examination, fracture of the head was observed with three large pieces, eighteen small pieces and several fragments returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion.[.] stereo microscope imaging was performed on the three large pieces of the head.Due to an intentional bias in the taper dimensions, the contact pattern characteristic of normal head/neck assembly is a continuous ring of stem metal transfer located near the proximal end of the tapered surface [1].The three large pieces were examined for evidence of this metal transfer ring, with arrows highlighting the ring.Figures show the presence of crack arrest lines which are indications of overload fracture.[.] characterisation using stereo microscopy confirmed the head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined." a review of the provided medical records by a clinical consultant further confirmed the event, but a root cause could not be determined from the information provided.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: ALUMINA C-TAPER HEAD 28MM/0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19070224
• Report Number: 0002249697-2024-00568
• Device Sequence Number: 20546457
• Product Code: LZO
• UDI-Device Identifier: 07613327101164
• UDI-Public: 07613327101164
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K971409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 17-2800E
• Device Lot Number: 47115702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 100 KG