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 Corroded (1131); Mechanical Problem (1384); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding disassociation and corrosion involving a lfit v40 cocr head that was mated with an accolade tmzf stem.The event for corrosion was not confirmed and the event for disassociation was confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant concluded: ¿x-ray printouts available for review include a series dated (b)(6) 2018, which is an ap of the pelvis, demonstrating an uncemented left total hip arthroplasty.The stem and acetabular shell are in nominal position.The stem trunnion has disassociated from the head, which remains reduced in the acetabulum.The tip of the stem is not visualized on this film.X-rays dated (b)(6) 2018 are two aps of the left hip, which are unchanged except the entire stem is now visualized and in nominal position.¿ [¿] ¿no clinical or past medical history and no early post-operative or serial x-rays are available for review.There is no indication of revision surgery having been performed or an operative report of the findings if such a procedure was undertaken.No examination of explanted components is available.Other than confirmation of the event description based upon the x-ray printouts, no determination can be made regarding the cause of this clinical event".Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the reported event of disassociation was confirmed.The subject device has been identified to be within scope of nc capa.Lot specific voluntary recall pfa was initiated for the lfit v40 cocr heads within scope of nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.The reported event of corrosion was not confirmed as insufficient information was provided because insufficient information was provided.Further information is needed to complete the investigation for determining root cause.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.Product surveillance will continue to monitor for trends.Corrective action: nc was initiated on 21-nov-2017 due to the occurrence rate for taper lock failure in the risk management files for specific lots of lfit v40 cocr heads.Capa for corrective actions associated with the nonconformance.Given the potential risk of nine (9) hazards identified in the hazards and harm evaluation, voluntary product recall pfa assessment was issued.Not available.

Event Description

Trunnion failure after 7 years of surgery.The stem and head are disassociated and there is corrosion, the surgeon wants to go for revision surgery.

Manufacturer Narrative

An event regarding disassociation and corrosion involving a lfit v40 cocr head that was mated with an accolade tmzf stem.The event for corrosion the event for disassociation were both confirmed.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 11 nov 2019.This inspection indicated: damage present on the surface of the taper is consistent with interaction between the head and trunnion.Damage consistent with contact against the stem following loss of taper lock was observed on the distal surface of the head.Dimensional & functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: a material analysis has been performed.The report concluded: damage consistent with loss of taper lock was observed on the neck and trunnion of the stem.Damage was observed on the taper of the head consistent with interaction with the stem trunnion.Damage consistent with contact against the stem following loss of taper lock was observed on the distal surface of the head.Eds and xrf showed that the stem and head base material were consistent with their respective drawings.Eds showed that the debris on the stem was consistent with biological material, an oxide, a corrosion product and material transfer from the head.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant concluded: ¿x-ray printouts available for review include a series dated (b)(6) 2018, which is an ap of the pelvis, demonstrating an uncemented left total hip arthroplasty.The stem and acetabular shell are in nominal position.The stem trunnion has disassociated from the head, which remains reduced in the acetabulum.The tip of the stem is not visualized on this film.X-rays dated (b)(6) 2018 are two aps of the left hip, which are unchanged except the entire stem is now visualized and in nominal position.¿ ¿no clinical or past medical history and no early post-operative or serial x-rays are available for review.There is no indication of revision surgery having been performed or an operative report of the findings if such a procedure was undertaken.No examination of explanted components is available.Other than confirmation of the event description based upon the x-ray printouts, no determination can be made regarding the cause of this clinical event.¿ product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the reported event of disassociation was confirmed.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 1757583 was initiated for the lfit v40 cocr heads within scope of nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

Trunnion failure after 7 years of surgery.The stem and head are disassociated and there is corrosion; the surgeon wants to go for revision surgery.

• 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
• MDR Report Key: 8265789
• MDR Text Key: 133709085
• Report Number: 0002249697-2019-00241
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MJMN7P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 80