MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-56E
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"surgeon followed surgical technique to prepare for implantation.When acetabulum was reamed to the appropriate size and implant was opened for implantation, surgeon couldn't get the implant to stick to the bone.Felt like the manufacturing finish of the product wasn't the usual standard.Surgeon uses this type of shell all the time and never had this issue before.Surgeon wants to know if there has been any reported issues with this shell size and lot number."."the surgeon stated the surface in contact with bone was the issue, referring to the surface on the outer diameter of the implant.This could be considered the coating.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding appearance involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: the device was received into decontamination and transferred to quality and engineering.During engineering analysis of the complaint, a surface spot was observed on the implant.Given that the device remained uncleaned for approximately one month prior to decontamination, the spot was hypothesized to be consistent with bacterial or fungal growth rather than a manufacturing defect.An additional cleaning cycle confirmed that embedded growth persisted within the porous coating.Importantly, photographic evidence demonstrated that this surface marking was not present at the time of surgery or in the immediate aftermath of the complaint.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: as per memo provided by the global quality & operations (gqo) team stated: based on this investigation, the implant¿s geometry, coating and spherical radius was produced in accordance with specifications, and all inspection checkpoints confirmed compliance.The post-use visual condition of the returned device was attributed to handling and storage delays prior to decontamination, rather than a product defect.While the surgeon perceived an atypical geometry or finish during surgery, no evidence from manufacturing, supplier processing, inspection, or dhr documentation supports a nonconformance.This complaint does not represent a product quality issue.The implant was manufactured and released within specification, and all inspection systems were validated.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: PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22874706
• Report Number: 0002249697-2025-00911
• Device Sequence Number: 20277700
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 Catalogue Number: 502-03-56E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown