MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problems Mechanical Problem (1384); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 04/07/2015

Event Type  Injury  

Event Description

The patient presented in the er with pain.The patient's left hip was then revised due to the stem and head disassociating which was discovered via x-ray.The cup was well fixed, so it remained implanted.A constrained liner and restoration modular stem was then implanted.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding disassociation involving a v40 head was reported.The event was confirmed.Method & results: -device evaluation and results: ¿movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction.Burnishing and wear was observed on the femoral head taper surfaces, consistent with movement against the stem trunnion.The medial femoral stem neck region exhibited severe material wear, consistent with point contact movement against the femoral head taper.The acetabular insert exhibited severe abrasion and material loss on areas of the articulating surface and the distal rim.These damages suggest that the worn trunnion dissociated from the femoral head, allowing the stem trunnion to directly impinge on the acetabular insert.Due to the damages present on the taper and trunnion surfaces, it was not possible to evaluate the condition of the taper lock that permitted movement to occur.¿ -medical records received and evaluation: ¿a material analysis reported dated february 29, 2016 of a #4 accolade stem, a 36/plus-5 v-40lfit head, and a trident 36/10 degree x3 insert include eleven photographs of the trunnion damage to an area of the insert.The conclusion of the report are: movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction; and due to damages on the surfaces it was not possible to evaluate the condition of the taper lock that permitted the motion.Based upon the information available for review, no determination can be made regarding the cause of the trunnion damage and disassociation of the head in this case.¿ -device history review: review of the device history records indicates (b)(4) devices were manufactured and accepted into final stock on 16-dec-2005 with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that based the medical assessment stated ¿a material analysis reported dated february 29, 2016 of a #4 accolade stem, a 36/plus-5 v-40lfit head, and a trident 36/10 degree x3 insert include eleven photographs of the trunnion damage to an area of the insert.The conclusion of the report are: movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction; and due to damages on the surfaces it was not possible to evaluate the condition of the taper lock that permitted the motion.Based upon the information available for review, no determination can be made regarding the cause of the trunnion damage and disassociation of the head in this case.¿.

Event Description

The patient presented in the er with pain.The patient's left hip was then revised due to the stem and head disassociating which was discovered via x-ray.The cup was well fixed so it remained implanted.A constrained liner and restoration modular stem was then implanted.

Manufacturer Narrative

Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

Event Description

The patient presented in the er with pain.The patient's left hip was then revised due to the stem and head disassociating which was discovered via x-ray.The cup was well fixed so it remained implanted.A constrained liner and restoration modular stem was then implanted.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4738667
• MDR Text Key: 5884064
• Report Number: 0002249697-2015-01406
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2017

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: 08/31/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: NEAMMA
• Other Device ID Number: STERILE LOT# MSH0609A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2016; 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR