MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER ELEVATED RIM 36 MM I.D. SIZE JJ; PROSTHESIS, HIP

Catalog Number 00875201136

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377); Reaction (2414)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: modular femoral stem press-fit plasma sprayed cementless size 12.5 cat# 00771301200 lot# 61553430, femoral head sterile product do not resterilize 12/14 taper cat# 00801803602 lot# 61459416, modular neck e 12/14 neck taper use with +0 heads only cat# 00784801200 lot# 61498536, shell with cluster holes porous 54 mm o.D.Size jj for use with jj liners cat#00875705401 lot#61543250, bone scr 6.5x30 self-tap cat#00625006530 lot#61526236.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 - 05080, 0002648920 - 2019 - 00863, 0001822565 - 2019 - 05081.

Event Description

It was reported that a patient underwent a primary right tha.Subsequently experienced recurrent dislocations and instability and workup revealed pseudotumor, elevated metal ions, and metallosis.Revision of right tha performed without complications approximately 9 years later.Surgeon reported extensive pseudotumor, tissue damage, trochanter resorption, metal debris, and corrosion.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.The following sections were updated/corrected.Updated: h2; h3; h6.Reported event was confirmed with operative notes provided.Review of revision operative notes state recent dislocations and instability.Pseudotumor noted throughout femur, resected.Metal debris noted, altr.Trunnionosis and metallosis noted.Lliquefaction of proximal femoral & hip girdle soft tissue (muscle loss and or detached & greater trochanter resorbed).Cup found stable.Stem removed cerclage wire placed for prevention while placing final component.Arthrex swivelock suture anchor was placed into proximal femur for reconstruction of muscle structures.No complications noted.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

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

• Brand Name: LINER ELEVATED RIM 36 MM I.D. SIZE JJ
• 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: 9383561
• MDR Text Key: 168441199
• Report Number: 0002648920-2019-00864
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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: 01/31/2015
• Device Catalogue Number: 00875201136
• Device Lot Number: 61412839
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/06/2020
• 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 Weight: 82