MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.; HIP, PROSTHESIS

Catalog Number 00620005422

Device Problems Corroded (1131); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Hematoma (1884); Necrosis (1971); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: modular femoral stem press-fit plasma sprayed cementless size 10 cat: 00771301000 lot: 61813586, femoral head cat: 00801803602 lot: 61841705, liner standard 3.5 mm offset 36 mm i.D cat; 00630505036 lot: 61796239.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.Product not returned.

Event Description

It was reported that the patient was revised due to pain, loosening, periprosthetic fracture, elevated metal ion levels, comorbidities, hematoma, necrosis, in vivo corrosion, heterotopic ossification, difficulty ambulating, decrease in adls, pseudotumor, failure to osseointegrate, osteolysis, dislocation, adverse local tissue reaction, and instability.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9033705
• MDR Text Key: 160684190
• Report Number: 0002648920-2019-00680
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Catalogue Number: 00620005422
• Device Lot Number: 61809032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57