MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 60 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Osteolysis (2377); Reaction (2414)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05399, 0002648920 - 2019 - 00910, 0002648920 - 2019 - 00911, 0002648920 - 2019 - 00912.

Event Description

It was reported the patient underwent total hip arthroplasty.Approximately 6 years later the patient is experiencing severe pain, limited rom, and swelling in the hip joint and will undergo revision surgery for explant of the products due to aseptic loosening, osteolysis, pseudotumor, and metallosis.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Consult notes identified early component wear and signs of release (loosening) compatible with aseptic release.Pain, swelling and limited range of motion.Osteolysis was identified around the cup and stem based on x-ray.Metallosis and pseudotumor was identified as well.Review of the device history record(s) for identified no deviations or anomalies during manufacturing.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.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 60 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: 9512682
• MDR Text Key: 172558498
• Report Number: 0002648920-2019-00912
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 00620006022
• Device Lot Number: 60824217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER HEAD CAT#00801802801 LOT#60975919; ZIMMER LINER CAT#00611006028 LOT#61675952; ZIMMER STEM CAT#00786201700 LOT#61291569
• Patient Outcome(s): Other