MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Reaction (2414); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: zimmer femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 4 extended offset reduced neck length, cat#: 65771100440, lot#: 62289137; zimmer femoral head sterile product do not resterilize 12/14 taper, cat#: 00801803603, lot#: 62346611; zimmer shell porous with cluster holes 50 mm, cat#: 00620205022, lot#: 62522176; zimmer liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, cat#: 00630505036, lot#: 62452970; zimmer bone scr 6.5x35 self-tap, cat#: 00625006535, lot#: 62417713.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02733.

Event Description

It was reported the patient underwent left hip revision approximately 5 years post initial implantation due to elevated cobalt levels.It was noted the cocr head was removed and replaced with a biolox head.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Review of the records demonstrated the following: the patient underwent a revision due to metallosis, altr, pseudotumor, tissue damage, and implant wear.Imaging taken revealed osteopenia.Blood testing revealed elevated cobalt levels.Revision operative notes revealed metallosis and altr with indications of chronic tearing of external rotators.The femoral component was well fixed and well positioned.Trunnion was found slightly burnished.A large pseudocyst seal was found posteriorly.Xrays were provided however they were not sent for review as the provided medical records were sufficient and the xrays would not enhance the investigation.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

It was reported the patient underwent left hip revision approximately 5 years post initial implantation due to elevated cobalt levels, metallosis, altr, pseudotumor, tissue damage, and wear.The head and liner were removed and replaced.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;d9;g3;h2;h3;h6.The following section was corrected: d4.H6: component code: mechanical (g04)- head.Product was returned and evaluated.A visual examination of the returned head identified outer spherical surface and flat area around the taper hole, which also showed scratches and dings.The taper hole showed dark foreign debris.No other damage was noted.The stem remains implanted, and photos were not provided.The issue was confirmed based on the provided medical records and the returned head with dark foreign debris.A review of the device history records identified no deviations or anomalies during manufacturing.The additional information does not change the outcome of the previous investigation.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 is available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10351985
• MDR Text Key: 201517839
• Report Number: 0002648920-2020-00360
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 62346611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/08/2020; 04/04/2024
• Supplement Dates FDA Received: 09/02/2020; 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female