MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/-5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	06-3299
Medical Device Problem Codes	Difficult to Insert (1316); Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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.Device evaluation is under review.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left hip.It was reported that after implantation, the femoral head was loose on the eon stem (to the degree where virtually no force was needed to manually remove the head).Head was tested on all the neck trials in the tray, and behaved the same way.A ceramic head was opened and locked on the stem with no issue.Procedure was complete successfully with a delay of approximately 2-3 minutes.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that it was in undamaged condition.Dimensional inspection: an operator on the bbs machining team conducted a visual and dimensional inspection of the returned part using the production released igs.A review of the gauges used for this inspection confirmed them all to be within calibration.All machined features were found to be within specified tolerances and conformed to the requirements outlined in the igs.No anomalies, irregularities, or damage were observed.Functional inspection: a functional inspection was performed by assembling the returned part with a c-taper stem.The head was able to lock onto the trunnion of the stem without issue.Clinician review: no medical records were received for review with a clinical consultant.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 after implantation, the femoral head was loose on the eon stem (to the degree where virtually no force was needed to manually remove the head).Head was tested on all the neck trials in the tray, and behaved the same way.The event was reviewed by the stryker mahwah bbs team which indicated the following: "investigation: following receipt of the complaint, a formal investigation was initiated by the stryker mahwah bbs team.A review of the manufacturing records showed that the part had passed all required manufacturing and inspection steps in accordance with the inspection guide sheet (igs).The product was machined with no product impacting nonconformances or quarantine events were recorded for this part or the overall lot.The lot originally consisted of twelve pieces, with one part scrapped during the polishing process for workmanship.The femoral head underwent stryker¿s standard decontamination.An operator on the bbs machining team conducted a visual and dimensional inspection of the returned part using the production released igs.A review of the gauges used for this inspection confirmed them all to be within calibration.All machined features were found to be within specified tolerances and conformed to the requirements outlined in the igs.No anomalies, irregularities, or damage were observed.Conclusion: in summary, the investigation into the completed manufacturing router and reinspection activity confirmed that the returned complaint part from catalog number 06-3299, lot a56lwe met all visual and dimensional requirements and followed the approved manufacturing process.As a result, this complaint is confirmed not to be manufacturing related." a functional inspection was also performed by assembling the returned part with a c-taper stem.The head was able to lock onto the trunnion of the stem without issue.Additionally, it should be noted that the following warning is stated in the "warnings" section of the ifu that was packaged with the device at the time of manufacture, "at time of assembly, machined taper surfaces must be clean and dry to ensure proper seating and assembly security.[.] c-taper heads must only be used with those howmedica osteonics stems which have a c-taper trunnion and are labeled accordingly.Both the 32mm and 36mm, -5mm neck femoral bearing heads must be used only with howmedica osteonics stems of size #9 or greater, with neck lengths of at least 35mm or with the head/neck stems with catalog suffixes of -0935 or greater.A 28mm, -3mm neck femoral bearing head must be used only with howmedica osteonics stems of size #7 or greater, with neck lengths of at least 30mm or with the head/neck stems with catalog suffixes of -0735 or greater.Use with stems other than those specified may severely limit range of motion, result in improper seating of the head or articular surface deformation.Improper use will negate the responsibility of howmedica osteonics corp.For the resultant mechanical performance of the device." 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.
Event or Problem Description
No new information.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/-5
• Common Device Name: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22078118
• Report Number: 0002249697-2025-00538
• Device Sequence Number: 21008058
• Product Code: LPH
• UDI-Device Identifier: 07613327016338
• UDI-Public: 07613327016338
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 06-3299
• Device Lot Number: A56LWE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Female