MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-52D

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

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 event was confirmed.Method & 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: a clear and certain cause for the development of radiolucent lines around a tritanium cup at 2-years post implantation cannot be provided as based upon current information.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: the exact root cause of the event could not be determined because insufficient information was received.However, a review by a clinical consultant indicated that: a clear and certain cause for the development of radiolucent lines around a tritanium cup at 2-years post implantation cannot be provided as based upon current information.However, further information such as return of device, patient history, operative reports, additional x-rayse & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

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

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5323619
• MDR Text Key: 34922310
• Report Number: 0002249697-2015-04488
• 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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 502-03-52D
• Device Lot Number: 44282101
• 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: 01/25/2013
• 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: 58 YR