MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: act artic e1 hip brg 28x44mm s50 dia28; catalog no#: ep-200150 ; lot#: 805600.Concomitant medical products: therapy date: (b)(6) 2020.The manufacturer did receive pictures and per for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the unknown side and underwent revision surgery due to pain, limited range of motion, grinding sound.

Event Description

Patient was implanted on right side and underwent revision surgery due to pain, limited range of motion, grinding sound.

Manufacturer Narrative

Additional information which was received on sep 10, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that product was implanted on (b)(6) 2020 and revised on (b)(6) 2020 due to pain, limited range of motion, grinding sound.Revision of liner and head was performed.Surgeon noted, metallosis stained tissue, subluxation occurring, with noted wear and deformity of implant.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: ap pelvis and single view of the right hip were received for investigation.The assessment of the imaging demonstrates a right total hip arthroplasty with cement fixation of the acetabular cup.There appears to be implant disassembly with dislocation of the acetabular cup polyethylene liner.Femoral component is intact.No fracture is seen.Incidental note made of a left total hip arthroplasty.Impressions: right total hip arthroplasty with possible implant disassembly with dislocation of the acetabular cup polyethylene liner.Medical records: medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following (summarized by hcp): complaint reported ¿ noise (grinding), pain and limited rom.Right hip subluxing femoral head & liner right total hip replacement, with revision of femoral head and poly liner (dual mobility).Metallosis of soft tissues, fluid appeared normal.Ceramic head ¿ scored.Unable to dislocate the dual mobility from liner.Hip was dislocated, and head & dual mobility bearing removed from morse taper, no issues found with trunnion, no impingement.Notes poly liner deformed superiorly.Cultures taken.No loosening, shell in anatomical position.28mm +3.5 ceramic head inserted inside 28 44 poly dual mobility bearing.Found to seat in cup well, no instability or subluxing noted with rom check, leg lengths were confirmed equal.No complications noted.Images: one short intraoperative movie intraoperative and 2 product photos / intraoperative pictures were received for review.The pictures show the explanted products while the movie shows how easily the head and the liner can be assembled and also be disassembled.Product evaluation: visual examination (see pictures attached): the visual examination shows a large area of metallic smearing on its articulation surface.No other deteriorations, deformations or imperfections can be seen.The metallic smearing most likely occurred due to the direct contact to the shell after the dislocation of the liner.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination for the reported products was approved by zimmer biomet.However, it is unknown if the entire construct is compatible.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that product was implanted on jan 29, 2020 and revised on may 6, 2020 due to pain, limited range of motion and grinding sound.Revision of liner and head was performed.Surgeon noted, metallosis stained tissue, subluxation occurring, with noted wear and deformity of implant.X-ray evaluation showed right total hip arthroplasty with possible implant disassembly with dislocation of the acetabular cup polyethylene liner.The head was received for investigation and showed metallic smearing that most likely occurred due to direct contact to the shell after the dislocation of the liner.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the review of the medical records and the combination of the head with a bipolar liner (head located inside the liner), it is unlikely that the head contributed to the dislocation of the acetabular cup polyethylene liner.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10117947
• MDR Text Key: 193930199
• Report Number: 0009613350-2020-00231
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430303
• UDI-Public: 00889024430303
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-028-03
• Device Lot Number: 2986097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 10/19/2020
• Supplement Dates FDA Received: 09/21/2020; 10/20/2020
• 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 Age: 41 YR