MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX HEAD HIP

Model Number N/A

Device Problems Fitting Problem (2183); Mechanical Jam (2983)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source documents 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.(b)(4).

Event Description

During initial surgery it was reported that the trial head got stuck to the stem.After trailing with the trial head the surgeon tried to remove it to implant the actual head but struggled in doing so.The surgeon thinks he might have scratched the stem neck while removing the trail head.An option head was used to complete the procedure to avoid further complications.

Manufacturer Narrative

Additional information was received on jan 13, 2021.D11- medical product: biolox delta, ceramic femoral head, s, 36/-3.5, taper 12/14; item# 00877503601; lot# 3020646 this follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: b5, h2.Corrections: b4, d1, d2, d4, d11, g4, g7, h3, h4, h10.Event update: during the surgery, the surgeon, while trying to remove the trial head, scratched the stem.An initial report has been submitted with (biolox delta, ceramic femoral head, s, 36/-3.5, taper 12/14; item# 00877503601; lot# 3020646) as the main product.But according to the new information received on jan 13, 2021, the issue is with the trial head and not the biolox delta head and hence, the biolox head has been considered as an associated device and the trail head as the main device in the reported event.The manufacturer received other source documents which will be reviewed as part on ongoing investigation, 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

The surgeon tried to remove a biolox trial head, during the surgery, and in doing so scratched the stem neck.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that during surgery on (b)(6) 2020 after trialing with the trial femoral head, the trial got stuck to the stem and the surgeon struggled to get it off.The surgeon thought he might have scratched the stem neck while trying to get it off, which is why a femoral option head was ultimately implanted instead.There was no surgical delay reported.Review of received data: no medical data relevant to the case has been received.Due diligence: further due diligence to support the conclusion was completed and documented.However, no additional information was provided.A zper was received in regards to the reported event containing the product id of the initially planned biolox delta femoral head (00-8775-036-01, lot 3020646) implant.It however remains unknown what the product id of the trial head are as well as the product id for the stem and ultimately implanted biolox option femoral head.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: it was reported that during surgery on (b)(6) 2020 after trialing with the trial femoral head, the trial got stuck to the stem and the surgeon struggled to get it off.The surgeon thought he might have scratched the stem neck while trying to get it off, which is why a femoral option head was ultimately implanted instead.There was no surgical delay reported.The investigation did not identify a nonconformance or a complaint out of box (coob).However, due to significant lack of information a detailed investigation could not be performed.Additionally, no product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the reported trial head is unknown.Based on the receipt of the zper, the reported event can be confirmed.However, 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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• Brand Name: BIOLOX HEAD HIP
• Type of Device: BIOLOX HEAD HIP
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11036423
• MDR Text Key: 241258463
• Report Number: 0009613350-2020-00600
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 08/13/2021
• Supplement Dates FDA Received: 02/08/2021; 08/18/2021
• 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