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 Failure To Adhere Or Bond (1031); Corroded (1131); Degraded (1153); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The patient visited the hospital in (b)(6) with pain and in stability in the hip the (b)(6) 2015, xray was taken and the head was loose from the stem.The patient had also been at (b)(6) hospital (b)(6) 2015 due to a clicking sound in the hip.Xray was taken.No action was taken.

Manufacturer Narrative

An event regarding instability involving a metal head was reported.The event was confirmed for disassociation following review by a medical professional and corrosion the following material analysis report.Method and results: device evaluation and results: visual inspection: a visual inspection was performed as part of the material analysis report.The articulating and distal surfaces of the v40 head are shown in figures 6 and 7, respectively.Damage was observed on the articulating surface of the v40 head, likely from articulating against the edge of the articulating surface of the insert.The taper of the v40 head is shown in figures 8 and 9.Scratches and black debris were observed on the taper.Elemental constituents of the v40 head included co-cr-mo, which are consistent with a cocr alloy (figure 13).Elemental constituents of the black debris included p-ti-ca-cr-mg-al-co (figure 14).The ca-p-mg is consistent with biological material.The high level on cr compared to co is consistent a corrosion product from the v40 head.The material analysis report concluded that: damage was observed on the insert, hip stem trunnion and v40 head taper.The damage observed was likely due to the hip stem trunnion dissociating from the v40 head taper, allowing the stem trunnion to articulate against the trident insert.Wear analysis could not be performed on the insert due to the damage observed.Black debris was observed on the v40 head.Eds was performed on the hip stem, v40 head and black debris.The hip stem was consistent with ti-6al-4v eli alloy.The v40 head was consistent with a cocr alloy.The black debris was consistent with biological material, a corrosion product from the v40 head, and the hip stem.No materials or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the medical records by a clinical consultant could confirm the event for disassociation but could not determine a root cause.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.However no material or manufacturing defects were observed on the returned devices.Further information such as operative reports, additional xrays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

The patient visited the hospital in (b)(6) with pain and in stability in the hip the (b)(6) 2015, xray was taken and the head was loose from the stem.The patient had also been at (b)(6) hospital (b)(6) 2015 due to a clicking sound in the hip xray was taken.No action was taken.

• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5258933
• MDR Text Key: 32450505
• Report Number: 0002249697-2015-04099
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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: 05/31/2012
• Device Catalogue Number: 6260-9-236
• Device Lot Number: TPXMHD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 102