MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LINER; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Degraded (1153); Unstable (1667); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/11/1990

Event Type  Injury  

Event Description

Patient stated they have a left stryker howmedica osteonics omniflex hip system and are experiencing pain intermittently when they turn a certain way, patient stated they feel like their hip will pop out of place possibly.Xrays from doctors have noted some wear and as a result want to revise patient accordingly once components are confirmed (if possible).

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown liner.The other devices listed in this report: cat # unk, lot # unk, description: unknown omniflex hip stem.Cat # unk, lot # unk, description: unknown head.Cat # unk, lot # unk, description: unknown cup.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device still implanted.

Manufacturer Narrative

An event regarding wear involving an unknown liner was reported.The event was confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: a medical review was performed and concluded, "after twenty-four years in situ, some poly wear is not unexpected.The omniflex system with uncemented acetabular shell from stryker is no longer available, but the surgeon can obtain an appropriate liner and modular head for these components by special order if a minimal revision surgery is planned.If the symptoms, in fact, require intervention this should be considered.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this late clinical finding." device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation concluded that liner wear is not unexpected for being implanted more than 24 years ago.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient stated they have a left stryker howmedica osteonics omniflex hip system and are experiencing pain intermittently when they turn a certain way, patient stated they feel like their hip will pop out of place possibly.X-rays from doctors have noted some wear and as a result want to revise patient accordingly once components are confirmed (if possible).

• Brand Name: UNKNOWN LINER
• Type of Device: HIP IMPLANT
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4776210
• MDR Text Key: 15966821
• Report Number: 0002249697-2015-01549
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 41 YR
• Patient Weight: 98