MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-56E

Device Problem Failure to Align (2522)

Patient Problem Pain (1994)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat.No.: 623-00-36e, trident 0° x3 insert 36mm id, lot code: mllr10; cat.No.: 2030-6525-1 6.5, cancellous bone screw 25mm, lot code: mlk74l; cat.No.: 2030-6525-1 6.5, cancellous bone screw 25mm, lot code: mlkhvl; cat.No.: 6052-1140s, secur-fit max 127 #11, lot code: mle4pd.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s infection.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.

Event Description

The patient had a tha done in 2012, was in a car accident and came to the physician complaining of pain.The cup was malaligned because of the car accident.During revision operation frozens were taken and the hip was infected.Everything was removed.

Manufacturer Narrative

An event reporting mal alignment regarding trauma involving a tritanium shell was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: no patient medical records were available for review.-device history review: a device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: based on the event description, it is likely the reported mal alignment was actually implant migration due to the forces sustained from the patient's car accident.It was further reported that were was an infection but this may have occured after the trauma.The exact cause could not be determined as no patient medical records were provided for review and the devices were not returned for evaluation.No further investigation is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The patient had a tha done in 2012.Was in a car accident and came to the physician complaining of pain.The cup was malaligned because of the car accident.During revision operation frozens were taken and the hip was infected.Everything was removed.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5308285
• MDR Text Key: 33831934
• Report Number: 0002249697-2015-04303
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/24/2015

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: 04/30/2017
• Device Catalogue Number: 502-03-56E
• Device Lot Number: MLH2K4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2012
• 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
• Patient Age: 47 YR