MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD 12/14 36X0

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-ray for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 right side and the superficial opening in the wound with serious drainage was closed.

Manufacturer Narrative

Investigation results were made available.Part specific investigation: less than 3 similar investigated events within the last 1 month and less than 6 similar investigated events within the last 6 months prior to the event date have been found for this item number.Result: issue evaluation request is not required.Lot specific investigation: less than 3 similar investigated events for the same lot number have been found.Result: issue evaluation request is not required.Investigation and conclusion: harm: patient dissatisfaction.Hazardous situation: infection.It was reported that an initial right total hip arthroplasty was performed (b)(6) 2015.Upon follow up, it was reported that the patient had a superficial opening in the wound with serous drainage.No redness, irritation, or signs of infection were noted.The wound was closed and redressed without further complication.Review of the device history records did not identify an anomaly.The gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this product.Therefore, it is highly unlikely that a disadvantageous product design favored or contributed to the infection.The ifu for endoprosthesis states that early or late infections are possible consequences of an implant and should be considered when implanting zimmer biomet devices.No product was returned or pictures provided.Therefore, a product evaluation could not be performed.The compatibility check showed that the product combination was approved by zimmer biomet.This device is used for treatment.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes dated (b)(6) 2015 were reviewed and no complications were noted.Medical notes dated (b)(6) 2015 were reviewed and identified patient had a superficial opening in the wound with serous drainage.The patient have had small areas of splitting suture in his groin crease but no purulent drainage and no erythema.In conclusion, it is unlikely that the biolox head caused or contributed to the reported wound healing disorder, nevertheless, a definitive root cause could not be determined.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).

Event Description

Upon follow up after initial right total hip arthroplasty, it was reported that the patient had a superficial opening in the wound with serous drainage.No redness, irritation, or signs of infection were noted.The wound was closed and redressed without further complication.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• Type of Device: BIOLOX DELTA HEAD 12/14 36X0
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8763376
• MDR Text Key: 150119651
• Report Number: 0009613350-2019-00420
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2791357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/12/2020
• 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 Weight: 104