MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MERIDIAN TMZF HIP STEM #2/12MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6265-1-005

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

It was reported the patient's right hip was revised due to dissociation of the femoral head from the stem.Intra-operatively, trunnion wear was noted.A meridian stem, lfit v40 head, and poly liner were revised to a restoration modular stem construct, mdm/ adm liner construct, ceramic head, and dall-miles cables.Rep also confirmed there are no allegations against the revised liner.

Event Description

It was reported the patient's right hip was revised due to dissociation of the femoral head from the stem.Intra-operatively, trunnion wear was noted.A meridian stem, lfit v40 head, and poly liner were revised to a restoration modular stem construct, mdm/ adm liner construct, ceramic head, and dall-miles cables.Rep also confirmed there are no allegations against the revised liner.

Manufacturer Narrative

Reported event an event regarding disassociation and wear involving a meridian stem which was mated with a lfit v40 cocr head was reported.The event of disassociation was confirmed based on clinician review of the provided medical records.Wear was confirmed through visual evaluation of the provided photograph.Method & results -product evaluation and results: no product was returned for evaluation however, photographs were provided for review.The photographs show a recently explanted stem and head.Blood and biological matter is visible on both devices.The trunnion of the stem appears worn/damaged.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: this inquiry reports a case of femoral head disassociation from the femoral stem with deformity of the trunnion that was revised with a restoration modular construct.I can confirm that this event took place since i was able to see the pre-op xray and the product usage sheet.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of head disassociation and trunnion deformity is multifactorial including implant factors, patient factors and surgical technique.-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 has been no other similar event for the lot referenced.Conclusion: the reported meridian stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.The event of disassociation and wear were confirmed and the root cause could not be identified.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MERIDIAN TMZF HIP STEM #2/12MM
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13115310
• MDR Text Key: 285189972
• Report Number: 0002249697-2021-02095
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Catalogue Number: 6265-1-005
• Device Lot Number: 16666901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2006
• 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): Hospitalization; Required Intervention
• Patient Sex: Female