MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KINECTIV TECHNOLOGY MODULAR NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Reaction (2414)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00784804201, modular neck r2 12/14 neck taper, lot: 62053330, part: 00801803602, femoral head 12/14 taper, lot: 62122125, part: 00875101236, neutral liner 36 mm i.D.Size kk, lot: 62033830, part: 00875101236, neutral liner 36 mm i.D.Size kk, lot: 62033830, part: 00625006525, bone screw self-tapping 6.5 mm dia.25 mm length, lot: 62119804, bone screw self-tapping 6.5 mm dia.25 mm length, lot: 62119812, part: 00875705601, shell with cluster holes porous 56 mm o.D.Size kk, lot: 62064692, part: 00771301100, modular femoral stem press-fit plasma sprayed cementless size 11, lot: 62030077.Multiple mdr reports were filed for this event, please see associated reports: head: 0002648920-2019-00392.

Event Description

It was reported that a patient underwent an initial hip procedure on.Subsequently, approximately six and a half years later the patient was revised due to pain, elevated cobalt levels, potential cobalt toxicity.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was confirmed with photographs and operative notes provided.Operative noted stated: following primary surgery, the patient suffered from progressive anterolateral hip pain with swelling.Review of radiographs showed significant intracapsular fluid collection and heterotopic ossification at the tip of greater trochanter.Evidence of adverse reaction of metal debris was noted.Review of the device history records 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.

Event Description

Additional information received from patient's legal counsel noted allegations of metallosis, corrosion, necrosis and pseudotumor.Attempts have been made and no further information has been provided.

• Brand Name: KINECTIV TECHNOLOGY MODULAR NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8683087
• MDR Text Key: 147468526
• Report Number: 0001822565-2019-02301
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K071856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00784804201
• Device Lot Number: 62053330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/19/2019; 07/18/2019
• Supplement Dates FDA Received: 07/16/2019; 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 69