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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Synovitis (2094); Tissue Damage (2104); Neck Stiffness (2434)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 2019 - 04001, 0001822565 - 2019 - 04002.

Event Description

It was reported patient underwent initial right total hip arthroplasty.Subsequently, the patient was revised approximately 7 years later due to pain, elevated metal ions, and tendinitis.During the revision, altr and tissue damage were noted with trunnion corrosion and poly debris within the shell locking ring.Significant heterotopic ossification was noted but some left in place to prevent further damage to surrounding tissue.The head, neck, liner, and locking ring were replaced without complication.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

Reported event was confirmed with operative notes provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following : the patient underwent a revision procedure due to adverse local tissue reaction, greater trochanter bursitis, and heterotopic bone formation.Lab tests showed that the patient had elevated metal ions.Pre-operative x-rays identified no issues related to the reported event.During the procedure, there was abundant scarring in the capsule that was causing stiffness along with heterotopic bone and granulation tissue.Upon removal of the head and neck, corrosion was noted at the trunnion.The locking ring was frozen due to poly debris getting into the locking groove.Upon removal of liner, a thin layer of yellowish plastic looking material was found on the inside of the cup.The locking ring was removed and the locking groove was cleaned well.A new zimmer biomet locking ring, liner, head, and neck were implanted.The large heterotopic bone fragment noted about the greater trochanter was left in place so as not to cause further destruction to the gluteus medius tendon.There were no other findings related to the reported event.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00734 , 0001822565 - 2019 - 04001.

• 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
• MDR Report Key: 9079989
• MDR Text Key: 158955337
• Report Number: 0002648920-2019-00684
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K073499
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 61934407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER CUP CAT#00620205822 LOT#61829641; ZIMMER LINER CAT#00630505836 LOT#61784774; ZIMMER NECK CAT#00784802300 LOT#61925275; ZIMMER STEM CAT#00771301500 LOT#61796970
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 103