MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 36MM/-2.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	06-3697
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	09/26/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding instability involving a metal head was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2014 a revision of the left total hip arthroplasty and left knee arthroscopic partial lateral meniscectomy was performed for a diagnosis of "(1) left hip instability¿.¿regarding the hip, it was noted, ''no evidence of loosening and no sign of infection of the hip is noted"."the construct tolerated combined hip flexion, adduction midline and internal rotation to 60 degrees before anterior impingement and posterolateral subluxation occurred.".According to implant labels the components were changed to a 28/plus-5 c-taper lfit head, a 28/48 admimdm x3 insert, and a 42e mdm liner".¿the patient's history of post-menopausal osteoporosis contributed to her fractures.The gamma nail construct functioned perfectly in situ resulting in healing of the stress fracture while maintaining its rigid fixation.The subsequent conversion to a total hip arthroplasty was indicated by progression of hip osteoarthritis.Two dislocations, indicating an unstable total hip arthroplasty, required revision to a more stable bearing construct like the mdm/adm bearing selected.Acetabular shell and stem are still retained as they have successfully osseointegrated.In the revision surgery of (b)(6) 2014 in which the mdm/adm bearing was implanted impingement of the joint was noted at the extremes of motion.The position of the well-fixed femoral and acetabular components were not changed, exposing the mdm/adm construct to the same impingement which was subsequently noted on the material analysis report of the explanted mdm/adm bearing.Dislocations are more common in revision surgery, and noting evidence of subsequent impingement evidence of the mdm/adm at revision would also cause instability.The revision to a constrained liner has apparently resulted in a stable hip as of the last documentation on (b)(6) 2018.Review of the medical records and material analysis report of the explanted components do not suggest component material or manufacturing factors as related to this clinical picture¿.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2014 a revision of the left total hip arthroplasty and left knee arthroscopic partial lateral meniscectomy was performed for a diagnosis of "(1) left hip instability.¿ ¿two dislocations, indicating an unstable total hip arthroplasty, required revision to a more stable bearing construct like the mdm/adm bearing selected.Acetabular shell and stem are still retained as they have successfully osseointegrated.In the revision surgery of (b)(6) 2014 in which the mdm/adm bearing was implanted impingement of the joint was noted at the extremes of motion.The position of the well-fixed femoral and acetabular components were not changed, exposing the mdm/adm construct to the same impingement which was subsequently noted on the material analysis report of the explanted mdm/adm bearing.Dislocations are more common in revision surgery, and noting evidence of subsequent impingement evidence of the mdm/adm at revision would also cause instability.The revision to a constrained liner has apparently resulted in a stable hip as of the last documentation on (b)(6) 2018.Review of the medical records and material analysis report of the explanted components do not suggest component material or manufacturing factors as related to this clinical picture".
Event or Problem Description
Patients friend called and stated that the patient had a left hip revision on (b)(6) 2014.She stated that patient was in pain since day one postop.Patient experienced pain, limited range of motion, would hear noises periodically and cant walk well.Patient had a revision on (b)(6) 2014.

• Brand Name: C-TAPER COCR LFIT HEAD 36MM/-2.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8175452
• Report Number: 0002249697-2018-04081
• Device Sequence Number: 1684201
• Product Code: LPH
• UDI-Device Identifier: 07613327032819
• UDI-Public: 07613327032819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 06-3697
• Device Lot Number: MNHPMH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54