MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 0580-1-501

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

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.Device not returned.

Event Description

During a tha revision, the surgeon removed a 50 no.1 cemented stem and attempted to replace the stem with another 50 no.1 ¿ he indicated the stem was wider at the bottom compared to the previous stem and therefore could not use it- this resulted in a delay to the case and ultimately a smaller stem being inserted.On 07sep21 - update: two stems were tried during the case and both were reported to have fit issues.Surgical delay was estimated at 120 minutes while attempting to remove cement mantle and place suitable stem.In addition, the patient was given 4 x units of red blood cells intra-operatively as result of blood loss throughout the case.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving an exeter stem was reported.The event was confirmed via labelling review.Method & results: device evaluation and results: visual inspection: visual inspection of the device indicated that the device was returned in used condition.Scratches and small nicks were observed on the device.This damage is consistent with attempted implantation/explantation.No further surface discrepancies were observed.Dimensional inspection: dimensional inspection was not performed because the device is not intended for cement-in-cement application, per exeter v40 stem cement-in-cement surgical technique.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the reported lot.This is for the other stem used for the same event /patient; therefore, no further trending is required for this commonality.Conclusion: surgical delay was reported during a total hip arthroplasty revision surgery due to a size/fit issue regarding two exeter stems that were attempted to be implanted.The two exeter stems are not in scope of the exeter v40 stem cement-in-cement surgical protocol.The cause of the event is user error.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During a tha revision, the surgeon removed a 50 no.1 cemented stem and attempted to replace the stem with another 50 no.1 ¿ he indicated the stem was wider at the bottom compared to the previous stem and therefore could not use it- this resulted in a delay to the case and ultimately a smaller stem being inserted.07sep21: update: two stems were tried during the case and both were reported to have fit issues.Surgical delay was estimated at 120 minutes while attempting to remove cement mantle and place suitable stem.In addition, the patient was given 4 x units of red blood cells intra-operatively as result of blood loss throughout the case.

• Brand Name: EXETER V40 STEM 50MM NO 1
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12568075
• MDR Text Key: 274455550
• Report Number: 0002249697-2021-01656
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Model Number: 0580-1-501
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G8049371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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