MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-232

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Erosion (1750); Edema (1820); Inflammation (1932); Pain (1994); Reaction (2414)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

It was reported that patient's right hip was revised due to pain and elevated cobalt (20.4) and chromium (3.0) levels.During procedure, surgeon reported extensive corrosion on the head and the head/ trunnion junction as well as extensive pseudo-tumor (not reported if any tissue sent to pathology).Examination and operative notes provided by the rep identify destruction of the right hip abductor mechanism, greater trochanteric erosion and weakness and "significantly apparent osteolysis in proximal aspect" of the greater trochanter, lytic destruction.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

An event regarding altr involving a metal head was reported.The event was confirmed.Device evaluation and results: not performed as the reported device was not returned for evaluation.A review of the provided medical records by a clinical consultant indicated: "the available medical records document a clear case of altr (adverse local tissue reactions) due to metallic debris:" "there is undoubtedly taper corrosion pathology between the trunnion of the accolade tmzf stem and femoral head but the cause remains unknown." review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Review indicated there have been no other similar events for the reported lot.A review of the provided medical records concluded "a review of the provided medical records by a clinical consultant indicated: "there is undoubtedly taper corrosion pathology between the trunnion of the accolade tmzf stem and femoral head but the cause remains unknown." the exact cause of the event could not be determined because insufficient information was provided.Additional information, including pathology reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that patient's right hip was revised due to pain and elevated cobalt (20.4) and chromium (3.0) levels.During procedure, surgeon reported extensive corrosion on the head and the head/trunnion junction as well as extensive pseudo-tumor (not reported if any tissue sent to pathology).Examination and operative notes provided by the rep identify destruction of the right hip abductor mechanism, greater trochanteric erosion and weakness and "significantly apparent osteolysis in proximal aspect" of the greater trochanter, lytic destruction.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: 32MM +4 LFIT V40 HEAD
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6986673
• MDR Text Key: 90532589
• Report Number: 0002249697-2017-03141
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• 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: 12/27/2017

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 Expiration Date: 07/18/2012
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 23218402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2007
• 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: 76 YR
• Patient Weight: 82