MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0230

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)

Event Date 09/29/2008

Event Type  Injury  

Manufacturer Narrative

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.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.H3 other text : device not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head and accolade tmzf plus hip stem on her right hip on or about (b)(6) 2008.It is further alleged that after implantation she experienced pain and suffering and loss mobility and required a revision surgery.

Manufacturer Narrative

Reported event: an event regarding altr and wear involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event of altr was confirmed.Method & results: -product evaluation and results: visual inspection, material analysis, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review with a clinical consultant indicated conclusion/assessment: the patient underwent a right tha in 2008 for oa.She underwent a left tha for djd but potential infection.The first hip had a tmzf stem the second an accolade 2, both with a v40 head.The right hip was revised for reported increased metal levels and pseudotumor on 09/10/2015.At the time of surgery metallosis, pseudotumor and abductor disruption were noted.Medical records before or after the surgery, radiographs, imaging studies, and/or laboratory studies were not provided for review.Event confirmation: a right tha can be confirmed.A left tha can be confirmed.A revision right tha can be confirmed.Pseudotumor and abductor involvement can be confirmed at the revision right tha.Metallosis, increased metal levels, pain, suffering, and/or loss of mobility cannot be confirmed without additional information and records.Root cause: the root cause of the right tha was oa.The root cause of the left hip djd and tha is unclear.The root cause of the revision right hip was clunking and pain and reported increased metal levels (not documented).The other findings could not be confirmed.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to altr, wear (metallosis/trunnionosis).The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head and accolade tmzf plus hip stem on her right hip on or about (b)(6) 2008.It is further alleged that after implantation she experienced pain and suffering and loss mobility and required a revision surgery.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18331993
• MDR Text Key: 330552485
• Report Number: 0002249697-2023-01564
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 06/30/2013
• Device Catalogue Number: 6021-0230
• Device Lot Number: 26919904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2008
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female