MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX, HEAD, M, 32/0, TAPER 12/14; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received x-rays and other source documents 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.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 right side and underwent revision surgery due to sudden pain and a cracking sound in the right hip.

Manufacturer Narrative

Additional information which was received on dec 08, 2020.Additionals: a2, b5, d1, d4, h2 corrections: b4, d7, g4, g7, h10 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

Patient was implanted on right side and underwent revision surgery due to sudden pain and and a cracking sound in the right hip.

Manufacturer Narrative

Event description: it was reported that the patient was implanted with ceramic head on (b)(6) 2014.On (b)(6) 2020 patient bent down and suddenly felt pain and a cracking sound in the right hip.Subsequently patient was revised on (b)(6) 2020.Review of received data: - x-rays: one ap x-ray was received of the right hip.The x-ray shows a fracture of the ceramic head with fragments located in the joint and in the shell.- surgical report: surgical report, dated (b)(4)2014: the surgical report has been reviewed, however no conspicuous findings relevant to the reported event have been identified.Surgical report, dated (b)(4)2020: the surgical report describes in the preoperative comments that the patient was implanted with hip prosthesis in 2014 due to primary coxarthrosis.It is described that the patient heard a cracking sound and suddenly felt pain the day before.After opening the joint the fractured head was observed which was removed in three bigger and some smaller fragments.The joint was rinsed and macroscopically no further ceramic fragments were observed.The insert was removed and a new insert was placed.During inspection of the stem it was observed that the taper was damaged heavily.It is reported that signs of corrosion is shown.The stem itself is well anchored and therefore not replaced.Product evaluation: - visual examination: the fractured sulox head was received for investigation.Three fragments of the head are received that assemble almost the entire head.At the engraving of the head some material is missing making it impossible to read the production number.A few individual metallic smearing in form of dots and lines can be observed on the articulation surface as well as on the fracture surface.The taper shows metallic smearing on one fragment reflecting a possible partial seating pattern.Further some possible organic deposit can be observed on the taper surface of all three fragments.The pattern and location of the possibly organic deposit resemble the stem's taper.More intense metallic smearing can be observed on the bottom of the taper which is most likely from the contact with the stem taper after the fracture.See pictures attached.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records could not be performed due to unknown lot number.Conclusion: it was reported that the patient was implanted with ceramic head on (b)(6) 2014.On (b)(6) 2020 patient bent down and suddenly felt pain and a cracking sound in the right hip.Subsequently patient was revised on (b)(6) 2020.The fractured sulox head was received for investigation.A few individual metallic smearing in form of dots and lines can be observed on the articulation surface as well as on the fracture surface.The taper exhibits some possible organic deposit.The pattern and location of the possibly organic deposit resembles the stem's taper.More intense metallic smearing can be observed on the bottom of the taper which is most likely from the contact with the stem taper after the fracture.The surgical report of the revision surgery also describes a damaged stem taper and signs of corrosion.It remains unknown if the damaged stem taper, the corrosion and the organic deposit occurred before the fracture and are possible contributing factors to the fracture.Based on the investigation the reported event can be confirmed.The investigation did not identify a nonconformance or a 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.It is possible that factors such as preparation of the stem and head taper prior to head mounting and other unknown factors contributed to the head fracture.Nevertheless, as the cause may be multifactorial, an exact root cause could not be identified.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.

Manufacturer Narrative

Investigation results have been updated as the lot# is now available: additional: d10, h2, h4, h6.Correction: b4, b5, g3, g6, h10.Note for this updated report: the lot# is now available.The outcome of the investigation has not changed due to the received lot#.Event description: it was reported that the patient was implanted with ceramic head on (b)(6) 2014.On (b)(6) 2020 patient bent down and suddenly felt pain and a cracking sound in the right hip.Subsequently patient was revised on (b)(6) 2020.Review of received data: x-rays: one ap x-ray was received of the right hip.The x-ray shows a fracture of the ceramic head with fragments located in the joint and in the shell.Surgical report: surgical report, dated (b)(6) 2014: the surgical report has been reviewed, however no conspicuous findings relevant to the reported event have been identified.Surgical report, dated (b)(6) 2020: the surgical report describes in the preoperative comments that the patient was implanted with hip prosthesis in 2014 due to primary coxarthrosis.It is described that the patient heard a cracking sound and suddenly felt pain the day before.After opening the joint the fractured head was observed which was removed in three bigger and some smaller fragments.The joint was rinsed and macroscopically no further ceramic fragments were observed.The insert was removed and a new insert was placed.During inspection of the stem it was observed that the taper was damaged heavily.It is reported that signs of corrosion is shown.The stem itself is well anchored and therefore not replaced.Product evaluation: visual examination: the fractured sulox head was received for investigation.Three fragments of the head are received that assemble almost the entire head.At the engraving of the head some material is missing making it impossible to read the production number.A few individual metallic smearing in form of dots and lines can be observed on the articulation surface as well as on the fracture surface.The taper shows metallic smearing on one fragment reflecting a possible partial seating pattern.Further some possible organic deposit can be observed on the taper surface of all three fragments.The pattern and location of the possibly organic deposit resemble the stem's taper.More intense metallic smearing can be observed on the bottom of the taper which is most likely from the contact with the stem taper after the fracture.See pictures attached.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations and/or anomalies.The review of the manufacturing documentation showed that all delivered items were released after incoming inspection.Further, the inspection-certificate confirms that the items are corresponding to the required geometries, to the customer specifications and show no surface defects.Conclusion: it was reported that the patient was implanted with ceramic head on (b)(6) 2014.On (b)(6) 2020 patient bent down and suddenly felt pain and a cracking sound in the right hip.Subsequently patient was revised on (b)(6) 2020.The fractured sulox head was received for investigation.A few individual metallic smearing in form of dots and lines can be observed on the articulation surface as well as on the fracture surface.The taper exhibits some possible organic deposit.The pattern and location of the possibly organic deposit resembles the stem's taper.More intense metallic smearing can be observed on the bottom of the taper which is most likely from the contact with the stem taper after the fracture.The surgical report of the revision surgery also describes a damaged stem taper and signs of corrosion.It remains unknown if the damaged stem taper, the corrosion and the organic deposit occurred before the fracture and are possible contributing factors to the fracture.Based on the investigation the reported event can be confirmed.The investigation did not identify a nonconformance or a 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.It is possible that factors such as preparation of the stem and head taper prior to head mounting and other unknown factors contributed to the head fracture.Nevertheless, as the cause may be multifactorial, an exact root cause could not be identified.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

Lot number has been received, no update to event description.

• Brand Name: SULOX, HEAD, M, 32/0, TAPER 12/14
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11028153
• MDR Text Key: 222088043
• Report Number: 0009613350-2020-00581
• Device Sequence Number: 1
• Product Code: KWY
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 17.32.06
• Device Lot Number: 2749786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• 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: 80 YR
• Patient Weight: 78