MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, L, 28/+3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medical report: femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 15 160 mm stem length cementless; item# 00786401500; lot# 60936564.The manufacturer did not receive x-rays for review.The manufacturer did not received the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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.(b)(4).

Event Description

Patient was implanted on the left side and underwent revision due to wear.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g4, g7, h10.Event description: it was reported that the patient was revised on 18 jul 2018 and was implanted with a biolox option head and e1 biomet active articulation hip system dual mobility bearing 50mm outside diameter on the left hip side.Mmc cup stayed in vivo.On 27 nov 2018 a closed reduction due to dislocation was performed.Patient was revised on 23 jan 2019 due to a failed left tha.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.Surgical report: the implantation report has been reviewed.Posterolateral approach.The femoral stem was found to be stably fixed to the bone and properly positioned.The acetabular component was found to be stably fixed to the bone.There was moderate osteolysis.Modest amount of metallosis around trunnion area.Decision was made to not revise the cup as risk for infection was in intermediate category.After trialing, soft tissue tension appeared appropriate.Hip was found to be stable.No conspicuous findings relevant to the reported event have been identified.The closed reduction medical report has been reviewed.Patient dislocated the hip when leading forward.First closed reduction was unsuccessful.Left lower extremity found to be shortened and internally rotated.X-ray control shows a posterior dislocation.Some lucency around the acetabular component, but no change in positioning.Reduction maneuver was performed.Fluoroscopic images confirmed the reduction of the hip and stability through function range of motion.X-rays confirmed that hip is reduced.The revision report has been reviewed.Failed tha.Change of acetabular component and femoral head.Implantation of biolox option head and depuy acetabular components (off-label use, combination with competitor's products).Upon opening fascia, polyethylene was found to be extracted, having disengaged from the ceramic femoral head.Ceramic femoral head showed metal transfer from rubbing in the metal cup.Therefore, change of cup required.Implantation of new products.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check for the femoral stem and head and dual mobility liner were performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.However, the combination of the dual mobility liner with the mmc cup has not been approved by zimmer biomet and is therefore considered an off-label use.Conclusion: it was reported that the patient was revised on (b)(6) 2018 and was implanted with a biolox option head and e1 biomet active articulation hip system dual mobility bearing 50mm outside diameter on the left hip side.Mmc cup stayed in vivo.On (b)(6) 2018 a closed reduction due to dislocation was performed.Patient was revised on (b)(6) 2019 due to a failed left tha.It was detected that the poly liner was disengaged from the ceramic head.Moreover, the ceramic head showed metal transfer from rubbing in the metal cup.Therefore, the mmc cup was exchanged as well.Based on the investigation the reported event can be confirmed.As no x-rays have been received, to positioning of the implants cannot be assessed.The patient has previously experienced another dislocation, which was treated with a closed reduction.This prior dislocation might have favored the recurrence of this event.Moreover, the reasons for hip dislocation are multifactorial, with contributing factors from the patient, the implant, and the surgical procedure.Additionally, an off label use has been performed by combining the mmc cup with the e1 dual mobility liner.It remains unknown of the non-approved product combination might have contributed to the reported event.Due to the unknown lot number of the biolox head a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).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)(6).The following reports are associated with this event 0009613350-2020-00242, 0009613350-2020-00243.

Event Description

No change to previoulsy reported event.

• Brand Name: BIOLOX OPTION, HEAD, L, 28/+3.5, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10127827
• MDR Text Key: 194315324
• Report Number: 0009613350-2020-00242
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430457
• UDI-Public: 00889024430457
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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: 00-8777-028-03
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention