MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER WITH CONSTRAINING RING; HIP PROSTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Joint Dislocation (2374)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Model #: 00889024126084.Concomitant medical products: item#: 00877702803, biolx opt hd/adpt 12/14 28+3.5, lot#: 2955283; item#: 00620105400, replacement locking ring for use with 54 mm shell, lot#: 63484424.Multiple mdr reports were filed for this event, please see associated report: liner: 0001822565-2019-00353.

Event Description

It was reported that the patient underwent an initial hip procedure and subsequently 2 1/2 years later, the patient was revised due to dislocation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Concomitant medical products: unknown stem - unknown part and lot, unknown cup - unknown part and lot.Reported event was confirmed by review of x-rays showing the femoral head is superolaterally positioned in relation to the cup.Visual inspection of the liner exhibits damage to the constraining tabs and rim feature.There are nicks and gouges noted on the ring and also one of the two constraining tabs shows damage.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: CONSTRAINED LINER WITH CONSTRAINING RING
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8292097
• MDR Text Key: 134563487
• Report Number: 0001822565-2019-00353
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K071718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00633405028
• Device Lot Number: 63157006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR