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

Catalog Number 6260-9-236

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Pain and leg length issues.Xray revealed head off of stem.Polyethylene also swapped.

Manufacturer Narrative

An event regarding alleged ¿pain, limb length issues and disassociation¿ involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: visual, dimensional and functional analysis could not be performed as the device was not returned.However, an image of the metal head was provided.Per review of the clinician, the metal head looked intact with dark material in the trunnion hole.Medical records received and evaluation: a review of the undated x-rays and provided images of the explanted devices by a clinical consultant indicated: ¿.The head is disassociated from the stem, however the trunnion geometry is not visible on this film.Indication from stryker corporation is that the v-40 36/plus-5 head in this case was subject to a voluntary recall.No patient demographics, no clinical or past medical history, no dated serial x-rays, and no examination of the explanted components are available for review.No revision operative report or description of the findings at this procedure are available.Based upon the information available for review, no determination can be made regarding the cause of this clinical event.¿ conclusions: 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.Although the lot was not provided, the lots associated with the reported catalog, date of implant and failure mode have been determined to be subject to the recall.Additionally, the root cause could not be determined as the consulting clinician indicated ¿no patient demographics, no clinical or past medical history, no dated serial x-rays, and no examination of the explanted components are available for review.No revision operative report or description of the findings at this procedure are available.Based upon the information available for review, no determination can be made regarding the cause of this clinical event.¿ no further investigation for this event is possible at this time.If additional information and/or return of the devices become available, this investigation will be reopened.

Event Description

Pain and leg length issues.Xray revealed head off of stem.Polyethylene also swapped.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED MANUFACTURER ENTITY
• 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: 6213524
• MDR Text Key: 63549168
• Report Number: 0002249697-2016-04048
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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 Catalogue Number: 6260-9-236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 89 YR