MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-50D

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009); Unintended Movement (3026)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2013, tritanium primary surgery was performed.2 years after the surgery, like a clear zone has appeared.

Manufacturer Narrative

An event regarding loosening involving a tritanium shell was reported.The medical review confirmed loosening and malpositioning.Method and results: device evaluation and results: the device was not received for analysis.Medical records received and evaluation: a review of the provided information by a clinical consultant indicated that: cup malposition in low anteversion with a deeply recessed cup position in the acetabular bone have contributed to overload in the cup implant-bone interface which is counterproductive for bone ingrowth conditions for the cup with radiolucent line formation as current intermediate result.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant conclude that "cup malposition in low anteversion with a deeply recessed cup position in the acetabular bone have contributed to overload in the cup implant-bone interface which is counterproductive for bone ingrowth conditions for the cup with radiolucent line formation as current intermediate result." if further information and/or device become available or the product is returned, this investigation will be re-opened.

Event Description

On (b)(6) 2013, tritanium primary surgery was performed.2 years after the surgery, like a clear zone has appeared.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5323614
• MDR Text Key: 34918254
• Report Number: 0002249697-2015-04487
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• 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: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 502-03-50D
• Device Lot Number: 45046801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• 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): Other
• Patient Age: 65 YR