MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CONSTRAINED LINER WITH CONSTRAINING RING 36 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer bone scr 6.5x30 self-tap cat#00625006530 lot#62292642.Zimmer bioloxâ® delta, ceramic femoral head, m, a, 36/0, taper 12/14 cat#00877503602 lot#2909462.Zimmer ms-30â®, stem, standard, cemented, 8, taper 12/14 cat#300049080 lot#2915186.Zimmer ms-30â®, distal centralizer, cemented, 㸠8/10 cat#0100358010 lot#2865842.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient was revised approximately 3 years later due to a squeaking hip implant.Patient was experiencing instability.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 no product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: CONSTRAINED LINER WITH CONSTRAINING RING 36 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10463751
• MDR Text Key: 204695254
• Report Number: 0002648920-2020-00388
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K101730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875801436
• Device Lot Number: 63097134
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention