MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; IMPLANT

Catalog Number 1236-2-852

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 03/20/2013

Event Type  Injury  

Event Description

It was reported after right hip revision, patient is experiencing thigh pain and has difficulty sitting.

Manufacturer Narrative

Additional devices listed in this report: cat # 6276-7-022, lot # caxm549d, description: mod con dist stem 22 x 155 mm; cat # 6276-1-025, lot # 41889904, description: 25mm mod rev hip body/bolt stdcomponent level 9006-1-025; cat # 6260-5-228, lot # 39509207, description: 28mm +4 v40 taper vit head; cat # 509-02-60f, lot # mlk77j, description: tritanium revision acetabular; cat # 626-00-46f, lot # 41704201, description: modular dual mobility insert; cat # 5260-5-020, lot # 42451302, description: osteolock bone screw 20mm; cat # 5260-5-024, lot # 42764602, description: osteolock bone screw 24mm; cat # 5260-5-035, lot # 42636901, description: osteolock bone screw 35mm.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Devices remain implanted.

Manufacturer Narrative

An event regarding pain involving an adm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the medical records by a clinical consultant concluded: x-ray findings were normal and also available x-rays document a perfect rm implantation with stable and unchanged position of all components over time.Second opinion surgeon feels the complaints of the patient were caused by his severe neuromuscular disease and not by his hip arthroplasty.No treatment is planned and all components remain to be implanted.The reported problems are purely of patient-related origin due to prior presence of muscular disease accompanied by severe muscular weakness causing an overload condition in his muscular system.There are no procedure-related or device-related aspects involved.Components remain to be implanted with no intention to perform another revision surgery thus far.As such, this pi case is not device-related -device history review: a device history review confirmed all devices were manufactured and accepted into finished goods with no relevant reported discrepancies.-complaint history review: a complaint history review confirmed no similar events for the reported lot.Conclusions: a review of the medical records by a clinical consultant concluded: x-ray findings were normal and also available x-rays document a perfect rm implantation with stable and unchanged position of all components over time.There are no procedure-related or device-related aspects involved.Components remain to be implanted with no intention to perform another revision surgery thus far.A capa trend analysis was conducted for the reported failure mode and concluded pain is a known possible adverse outcome of surgery.

Event Description

It was reported after right hip revision, patient is experiencing thigh pain and has difficulty sitting.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: IMPLANT
• 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: 4352363
• MDR Text Key: 5205800
• Report Number: 0002249697-2014-04800
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 41874401
• Other Device ID Number: STER. LOT 1210O261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2012
• 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): Other
• Patient Age: 68 YR
• Patient Weight: 98