MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-040

Device Problems Corroded (1131); Material Discolored (1170); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374); Reaction (2414); No Code Available (3191)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer reported that the female patient presented with dislocation.She was revised on (b)(6) 2016 and the surgeon reported metallosis.Images of explanted devices indicate black on stem trunnion and inside the head.

Manufacturer Narrative

An event regarding corrosion involving an metal head was reported.The event was confirmed.Method and results: device evaluation and results: device was not returned however, provided explanted images shows some scratches, damage, blood stains and black stain on head.Medical records received and evaluation: the provided medical records were reviewed by consulting clinician who indicated: "the primary harm involved is recurrent instability of the hip.The poor condition of the hip abductors undoubtedly plays a role in the recurrent instability.No evidence of implant design or manufacturing is presented.The patient had mildly elevate blood co,cr and ti ion levels and staining of the tissues with metallosis.The nature of the staining i.E., is not known.While it might be related to corrosion and wear of the trunion and head it also may reflect abnormal wear of the edge of the titanium cup as it articulated abnormally with a dislocated femoral head." device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event of metallosis is confirmed however, the root cause could not be determined.No evidence of implant design or manufacturing is presented.Further information such as primary operative report, implant records, dated pre- and post-op x-ray images, clinical notes and the explanted devices are needed to complete the investigation for determining root cause.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

The customer reported that the female patient presented with dislocation.She was revised on (b)(6) 2016 and the surgeon reported metallosis.Images of explanted devices indicate black on stem trunnion and inside the head.The surgeon further reported that the muscle of the abductors destroyed by armd.Patient had dislocation of thr 3 times prior to revision.This is the right side.

Manufacturer Narrative

Additional information noted upon file closure, therefore lot #, expiration date and device manufacture date was updated.

Event Description

The customer reported that the female patient presented with dislocation.She was revised on (b)(6) 2016 and the surgeon reported metallosis.Images of explanted devices indicate black on stem trunnion and inside the head.The surgeon further reported that the muscle of the abductors destroyed by armd.Patient had dislocation of thr 3 times prior to revision.This is the right side.

• Brand Name: V40 COCR LFIT HEAD 40MM/-4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6087687
• MDR Text Key: 59453382
• Report Number: 0002249697-2016-03532
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K061434
• 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,Followup
• Report Date: 09/12/2017

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: No Information
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 6260-9-040
• Device Lot Number: METEHV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; 08/16/2017
• Supplement Dates FDA Received: 01/27/2017; 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2009
• 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 Age: 78 YR