MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00500105200 ¿ multipolar cup ¿ 64707287; 802202803 ¿ cocr head ¿ 64877525; unknown stem - unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product was discarded.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: 0002648920 - 2021 - 00110.

Event Description

It was reported that patient presented to the hospital emergency department due to right hemi arthroplasty dislocation approximately 20 days after implantation.During closed reduction, the outer ball and plastic disassociated.The patient was admitted for a revision surgery.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Medical notes were reviewed and the following were identified: 75yo male fell asleep on couch with 'his leg over the back' and not sure when it dislocated.Right periprosthetic hip dislocation with failure of closed reduction in ed, which resulted in dissociation of the bipolar head.Right hip open reduction with replacement of bipolar head.Upon opening, found 'outer ball and plastic was dissociated', large hematoma, which would not be considered abnormal post dislocation and attempts of closed reduction.Some tissue damage was noted and 'friable' areas were debrided and irrigated.The bipolar head was removed, cultures taken, and new head placed.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS
• 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: 11782310
• MDR Text Key: 249204442
• Report Number: 0002648920-2021-00111
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115453
• UDI-Public: (01)00889024115453(17)280906(10)64774232
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500105028
• Device Lot Number: 64774232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• 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