MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-5-026

Device Problem Fitting Problem (2183)

Patient Problem Unequal Limb Length (4534)

Event Date 06/22/2021

Event Type  Injury  

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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Metal head 26mm/±0mm was attached to the neck of an accolade ii 132 degree #4 with a head impactor and hammer.During reduction with a centrax 46mm head, the connection between the neck and the head was too loose and it fell out immediately.When surgeon removed the head and put the head trial on the stem neck, it fit fine.The doctor's opinion was that the inner diameter of the metal head was too large.As a substitute, metal head 26mm±0 and centrax 48mm were used.Leg length increased by 3 mm.Please investigate whether the inner diameter of the metal head is different from the normal v40.

Event Description

Metal head 26mm/±0mm was attached to the neck of an accolade ii 132 degree #4 with a head impactor and hammer.During reduction with a centrax 46mm head, the connection between the neck and the head was too loose and it fell out immediately.When surgeon removed the head and put the head trial on the stem neck, it fit fine.The doctor's opinion was that the inner diameter of the metal head was too large.As a substitute, metal head 26mm±0 and centrax 48mm were used.Leg length increased by 3 mm please investigate whether the inner diameter of the metal head is different from the normal v40.

Manufacturer Narrative

Corrected data: d4 cat # & lot details.Reported event: 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 noted the following: visual inspection of the returned parts noted nothing of significant on the returned part.Dimensional inspection: dimensional inspection of the returned device noted the following: as part of the investigation by stryker, the part was measured as per the following steps as part of the inspection process.Functional inspection: functional inspection was not performed because the event does not relate to device function.Material analysis: material analysis was not performed because the event does not relate to material integrity.-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: 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: 26MM STD V40 TAPER VIT HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 12157297
• MDR Text Key: 261830472
• Report Number: 0002249697-2021-01187
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327012828
• UDI-Public: 07613327012828
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121308
• 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: 03/04/2022

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 Model Number: 6260-5-026
• Device Catalogue Number: 6260-5-126
• Device Lot Number: 81925503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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