MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Tissue Damage (2104); Joint Dislocation (2374)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784804201, 61745801, modular neck r2 12/14 neck taper use with +0 heads only.00801803602, 62209912, femoral head sterile product do not resterilize 12/14 taper.00620205822, 62196455, shell porous with cluster holes 58 mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.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: 0001822565-2020-01977, 0001822565 - 2020 - 02384.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately five years post implantation due to chronic dislocations and impingement.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.Medical records were provided and reviewed by a health care professional.The patient underwent a revision procedure due to chronic dislocation and impingement.The patient experienced 4 dislocations due to flexion internal rotation type movement.A large trochanteric overgrowth impinged on the lateral aspect of the iliac wing.The head, neck, and liner were replaced and the limb length was extended.It was noted that an additional revision of the contralateral side was necessary due to metallosis.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.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: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: 10226903
• MDR Text Key: 197540942
• Report Number: 0002648920-2020-00337
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62209912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROSTHESIS, HIP
• Patient Outcome(s): Hospitalization; Required Intervention