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

Catalog Number 6260-9-036

Device Problems Material Disintegration (1177); Metal Shedding Debris (1804); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Patient was implanted on (b)(6) 2008 with a pta at (b)(6) hospital.On (b)(6) 2015 he was undergone a revision of the head (from metal to ceramic (new femoral head (b)(4), lot 49985005 ) and the insert (new insert (b)(4)) at (b)(6) hospital in (b)(6).On (b)(6) 2015, it was indicated that the reason for the revision was metallosis.

Manufacturer Narrative

An event regarding altr (metallosis) involving a metal head was reported.The event was confirmed from the medical review.Method & results: -device evaluation and results: not performed as the device was not returned for analysis.-medical records received and evaluation: a review of the medical records by a clinical consultant noted: issue with two revisions performed within 9-months of each other after primary abg-2/trident implantation in 2008 in a now (b)(6)-year old ((b)(6)) female patient with unknown body weight and activity level.The first revision in (b)(6) 2015 was indicated for metallosis when exchange of femoral head and insert was performed.In (b)(6) 2015 an abg-2 neck fracture occurred requiring another revision when a zimmer revision stem was implanted.No further clinical details are available.X-rays post neck fracture document an adequate implantation of the abg stem but the trident cup has a low effective inclination due to use of a 10° liner plus absent anteversion while also significant heterotopic ossifications (ho) are present in and around the joint space, brooker grade-3.Explant pictures confirm the neck fracture while the rim of the cup liner shows an impingement ¿dimple¿.No explants were returned for investigation at any time.Two different events were reported for (b)(6) 2015 respectively but based upon available information, they both share the same underlying failure mechanisms that were not adequately recognized the first time and therefore led to the second revision.Because both reported events share the same root cause of failure both reported cases are not device-related but were caused by an adverse mix of procedure-related factors (cup malposition) and patient-related factors regarding presence of heterotopic ossifications.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the medical records by a clinical consultant concluded that the was caused by an adverse mix of procedure-related factors (cup malposition) and patient-related factors regarding presence of heterotopic ossifications.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 was implanted on (b)(6) 2008 with a pta at(b)(6) hospital.On (b)(6) 2015 he was undergone a revision of the head (from metal to ceramic (new femoral haed 6570-0-132 lot 49985005 ) and the insert (new insert 623-10-32e) at (b)(6).On (b)(6) 2015, it was indicated that the reason for the revision was metallosis.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5147251
• MDR Text Key: 28139372
• Report Number: 0002249697-2015-03356
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

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: 05/31/2013
• Device Catalogue Number: 6260-9-036
• Device Lot Number: RMAMHE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2008
• 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: 68 YR