MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 6260-9-336

Device Problems Corroded (1131); Material Disintegration (1177); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Osteolysis (2377)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown 36mm head.A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient presented with pain was revised due to head dislocating from the stem in patient's left hip.Surgeon revised the trident x3 liner and a 36mm head.Surgeon stated that osteolysis was noted during the revision.

Manufacturer Narrative

An event regarding the disassociation of a head from a stem involving dv40 cocr lfit head 36mm/+10 was reported.The event was not confirmed.Method & results: device evaluation and results: the head's female taper showed signs of wear/damage.A material analysis report dated 10-sep-2015 concluded no material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the investigation concluded that the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary and revision operative reports as well as patient history and follow-up notes are needed to complete the investigation.It was also concluded that there is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient presented with pain was revised due to head dislocation from the stem in patient's left hip.Surgeon revised the trident x3 liner and a 36mm head.Surgeon stated that osteolysis was noted during the revision.

Manufacturer Narrative

Additional information: remedial action initiated; correction/removal rpt number.Lot specific voluntary recall 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 (b)(6)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

Patient presented with pain was revised due to head dislocting from the stem in patient's left hip.Surgeon revised the trident x3 liner and a 36mm head.Surgeon stated that osteolysis was noted during the revision.

Manufacturer Narrative

An event regarding the alleged wear, disassociation and corrosion involving a metal head was reported.The reported event for wear and corrosion were confirmed via mar.Method & results: device evaluation and results: the head's female taper showed signs of wear/damage.A material analysis report was performed and concluded: "damage modes on the articulating surfaces of the trident x3 are commonly observed damage modes on uhmwpe.A 400 series stainless steel alloy particle was found on the articulating surface of the v40 head.This particle was interacting with the articulating surfaces of the v40 head and trident x3, causing damage to both surfaces.Eds was performed on the metal debris from the articulating surface of the trident x3, and was consistent with a cocr alloy.This debris was likely created by wear against the 400 series particle found on the articulating surface.Eds was performed on the base alloy of the v40 head, and was consistent with a cocr alloy.Eds was also performed on the black debris from the v40 head, and was consistent with a corrosion process.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the reported event for wear and corrosion are confirmed based on the results of the material analysis report indicating "[.] this debris was likely created by wear against the 400 series particle found on the articulating surface.Eds was performed on the base alloy of the v40 head, and was consistent with a cocr alloy.Eds was also performed on the black debris from the v40 head, and was consistent with a corrosion process.No material or manufacturing defects were observed on the surfaces examined." lot specific voluntary recall 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.If additional information become available, this investigation will be reopened.

Event Description

Patient presented with pain was revised due to head dislocating from the stem in patient's left hip.Surgeon revised the trident x3 liner and a 36mm head.Surgeon stated that osteolysis was noted during the revision.Update: damage modes on the articulating surfaces of the trident x3 are commonly observed damage modes on uhmwpe.A 400 series stainless steel alloy particle was found on the articulating surface of the v40 head.This particle was interacting with the articulating surfaces of the v40 head and trident x3, causing damage to both surfaces.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5031362
• MDR Text Key: 24086918
• Report Number: 0002249697-2015-02781
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 08/21/2018

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: 04/30/2011
• Device Catalogue Number: 6260-9-336
• Device Lot Number: P40MEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: 05/04/2018; 07/24/2018
• Supplement Dates FDA Received: 05/31/2018; 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 145