MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 14 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-014
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "cone body restoration conical to move post operation in retroversion.".
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported: "cone body restoration conical to move post operation in retroversion.".
Additional Manufacturer Narrative
An event regarding malposition involving a restoration modular stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned stem indicated nothing remarkable was observed.The device appears in undamaged condition.-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 the patient was revised due to the cone body restoration conical being in retroversion.Visual inspection of the returned stem indicated nothing remarkable was observed.The device appears in undamaged condition.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: MOD CON DIST STEM 14 X 155 MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14389786
• Report Number: 0002249697-2022-00689
• Device Sequence Number: 20052303
• Product Code: LPH
• UDI-Device Identifier: 04546540643728
• UDI-Public: 04546540643728
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 05/19/2026
• Device Model Number: 6276-7-014
• Device Catalogue Number: 6276-7-014
• Device Lot Number: CAXYD06E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 60 KG